BD Hypoint™ 300253Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00382903002535), received between Feb 4, 2019 and Mar 14, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE BD HYPOINT¿ NDL25GA5/8IN DETACHED FROM THE ORANGE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT ALSO REPORTS HAVING 2 DEFECTIVE SYRINGES 1)PT REPORTS EXPERIENCING 3 ABDOMINAL AND LARYNGEAL ATTACKS SINCE THEIR LAST FILL AS FOLLOWS: (B)(6) 2024 SEVERE SWELLING, (B)(6) 2025 MODERATE SWELLING, (B)(6) 2025 MODERATE SWELLING. PT REPORTS THAT ALL ATTACKS WERE TREATED WITH 1 DOSE OF PRN FIRAZYR EACH; RESOLUTION DATES UNKNOWN. PT REPORTS THAT THEY HAD AN ER VISIT IN (B)(6) 2024 DUE TO AN (UNSPECIFIED) REACTION TO ANTIBIOTICS. DATES OF ADMITTANCE AND DISCHARGE OR LENGTH OF ER STAY IS UNKNOWN. PT ALSO REPORTS HAVING 2 DEFECTIVE SYRINGES. PT REPORTS THAT THEY HAD A LARYNGEAL ATTACK THIS MORNING (B)(6) 2025 AND TWO OF THEIR FIRAZYR SYRINGES MALFUNCTIONED. PT REPORTS THAT WITH THE FIRST SYRINGE THE NEEDLE FELL OUT OF THE ORANGE NEEDLE HUB THAT ATTACHES TO THE BARREL. PT HAD NO EXTRA NEEDLES SO THAT DOSE HAD TO BE WASTED. CONSENT TO CONTACT THE PATIENT'S HCP WAS NOT ASKED. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. 2) PT REPORTS THE SECOND SYRINGE'S PLUNGER MALFUNCTIONED AND THEY WERE ONLY ABLE TO GET 3/4 OF THE DOSE, WHICH WAS ENOUGH MED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609397 ↗
• MalfunctionNov 6, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD HYPOINT¿HYPODERMIC NEEDLE SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE PATIENT STATED THAT WHEN SHE WENT TO GIVE HER DOSE, THE NEEDLE FELL OUT OF THE SYRINGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20625132 ↗
• MalfunctionAug 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE BD HYPOINT¿HYPODERMIC NEEDLES WERE MISSING GLUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN A VISUAL INSPECTION OF 800 NEEDLES WE HAVE OBSERVED 88 NEEDLES WITH A SPOT THAT LACKS GLUE INSIDE THE HUB ADDITIONALLY WE FOUND NEEDLE WITH LACK OF GLUE IN THE BOTTOM OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930908 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THE BD HYPOINT¿ NDL25GA5/8IN NEEDLE BROKE OFF DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER ICATIBANT NEEDLE BROKE OFF DURING INJECTION. NEEDLE BROKE OFF DURING INJECTION & HALF PART REMAINING OF NEEDLE IN THE SKIN OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164457 ↗
• MalfunctionApr 23, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT 3 OF THE BD HYPOINT¿HYPODERMIC NEEDLES WERE DAMAGED. REPORT 2 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT REPORTED THAT ALL 3 SYRINGES FROM LAST DELIVERED OF MEDICATION WERE DEFECTIVE. THE PLUNGERS HANDLES WERE NOT ATTACHED TO GRAY STOPPER INSIDE THE SYRINGE, PLUNGERS WOULD NOT WORK ON ANY OF THE SYRINGES, NEEDLES WERE OFF SET THERE WAS SOMETHING WHITE AROUND THE NEEDLES THAT "DON'T THINK THAT SHOULD HAVE BEEN THERE". UNKNOWN IF THE PRODUCT IS ON HAND FOR RETURN. UNKNOWN IF THE MD IS AWARE. UNKNOWN IF THE PATIENT ADMINISTERED THE PRODUCT. UNKNOWN IF THE PATIENT MISSED ANY DOSES DUE TO THE DEFECTIVE ITEMS. UNKNOWN IF THE MD IS AWARE. UNKNOWN DATE OF OCCURRENCE. UNKNOWN IF THE PATIENT EXPERIENCED ANY SIDE EFFECTS DUE TO A DEFECTIVE PRODUCT. NO FURTHER INFORMATION, DATES, OR DETAILS REPORTED. CONSENT TO CONTACT THE PATIENT'S HCP WAS NOT ASKED. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162131 ↗
• MalfunctionApr 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 3 OF THE BD HYPOINT¿HYPODERMIC NEEDLES HAD FOREIGN MATTER. REPORT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT REPORTED THAT ALL 3 SYRINGES FROM LAST DELIVERED OF MEDICATION WERE DEFECTIVE. THE PLUNGERS HANDLES WERE NOT ATTACHED TO GRAY STOPPER INSIDE THE SYRINGE, PLUNGERS WOULD NOT WORK ON ANY OF THE SYRINGES, NEEDLES WERE OFF SET THERE WAS SOMETHING WHITE AROUND THE NEEDLES THAT "DON'T THINK THAT SHOULD HAVE BEEN THERE." UNKNOWN IF THE PRODUCT IS ON HAND FOR RETURN. UNKNOWN IF THE MD IS AWARE. UNKNOWN IF THE PATIENT ADMINISTERED THE PRODUCT. UNKNOWN IF THE PATIENT MISSED ANY DOSES DUE TO THE DEFECTIVE ITEMS. UNKNOWN IF THE MD IS AWARE. UNKNOWN DATE OF OCCURRENCE. UNKNOWN IF THE PATIENT EXPERIENCED ANY SIDE EFFECTS DUE TO A DEFECTIVE PRODUCT. NO FURTHER INFORMATION, DATES, OR DETAILS REPORTED. CONSENT TO CONTACT THE PATIENT'S HCP WAS NOT ASKED. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161638 ↗
• MalfunctionApr 18, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD HYPOINT¿ 25GA5/8IN NEEDLE, LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MI INVOLVED. CALLER WAS A FEMALE PHARMACIST. PHARMACIST NOTED THAT A FEMALE PATIENT IN HER 40S FOUND A LEAKAGE FROM FIRAZYR 30MG PFS (1 UNIT) WHILE ATTEMPTING TO ADMINISTER IT AT HER HOME ON (B)(6) 2024. PATIENT WAS ONLY ABLE TO RECEIVE THE HALF DOSE ON THE DAY. PHARMACIST STATED THAT THE PATIENT WAS PRESCRIBED FIRAZYR 30MG PFS FOR HAE CAUSED BY C1-ESTERASE INHIBITOR DEFICIENCY. PATIENT ADMINISTERS FIRAZYR 30MG PFS IN A PRN MANNER SUBCUTANEOUSLY. PHARMACIST STATED THAT SHE IS UNABLE TO PROVIDE FURTHER AE DETAILS ON THE LINE. PHARMACIST STATED THAT THE FIRAZYR 30MG PFS IS CURRENTLY AT THE PATIENT'S HOME, AND SHE IS NOT ABLE TO PROVIDE ITS BATCH NUMBER AND EXPIRY DATE. SHE STATED THAT SHE WILL KEEP THE THE FIRAZYR 30MG PFS IN HER HOSPITAL FOR QUALITY INVESTIGATION ONCE THE PATIENT BRINGS THE FIRAZYR 30MG PFS TO THE HOSPITAL ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134032 ↗
• MalfunctionApr 16, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD HYPOINT¿HYPODERMIC NEEDLE THE NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT ADVISED THAT SHE INJECTED YESTERDAY AND THE INJECTION DIDN¿T WORK. SHE HAD 3, SO USED ANTHER WHICH WORKED. NO FURTHER INFORMATION PROVIDED. ADDITIONAL DETAILS RECEIVED: DESCRIPTION OF EVENT: PT MUM ADVISED THAT WHEN SHE TRIED USING THE FIZAYR THE INJECTION SHE FOUND THE INJECTION DID NOT GO IN AND HAD LEFT MARKS AND PRICKED THE SKIN AND ADVISED NONE OF THE LIQUID WENT IN DEVICE DETAILS: FIZAYR HAS THE DEVICE BEEN DROPPED? NO WAS THE DEVICE INSPECTED BEFORE USE & IN DATE? YES WAS THE INDICATOR WINDOW OBSERVED COLOUR FILL QUANTITY OBSERVED? YES HOW LONG WAS THE PEN LEFT OUT OF THE FRIDGE PRIOR TO ADMINISTRATION? NO DID YOU PINCH THE SKIN (IF REQUIRED)? YES HOW WAS THE DEVICE CAP REMOVED? (TWISTED OR PULLED?) PULLED WHERE DID YOU INJECT? DO YOU ROTATE THE INJECTION SITE REGULARLY? STOMACH ARE YOU ABLE TO HOLD THE INJECTION AT A 90-DEGREE ANGLE? YES HOW LONG WAS THE DEVICE HELD FOR AT THE INJECTION SITE? NO DID THE PATIENT HEAR A CLICK? HOW MANY? NO DID THE INSPECTION WINDOW CHANGE COLOUR BEFORE THE DEVICE WAS REMOVED FROM THE SKIN? NO DID TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116379 ↗
• MalfunctionApr 8, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT REPORTED TO THE NURSE CASE MANAGER VIA EMAIL, "I HAD TO TAKE FIRAZYR EARLY THIS MORNING. THE LOT NUMBER IS "TSVJ09A15" AND THE EXPIRY IS 09/2024. I WAS ONLY ABLE TO INJECT HALF OF THE DOSE FOR SOME REASON AND THEN IT FELT LIKE THE PLUNGER WAS RESISTING. I HAVE NO OTHER DOSES, BUT 3 TAKHZYRO STILL WHICH I HAVEN'T BEEN TAKING. SYMPTOMS: MILD SWELLING IN WRIST/ HAND 48 HOURS PRIOR, THEN GI CRAMPING BEGINNING EVENING ON (B)(6) 2024 THAT WORSENED UNTIL AROUND 2AM (B)(6) 2024 WITH NAUSEA, PAIN AND DIZZINESS, PASSING OUT AND HOT/ COLD FLASHES BEFORE I TOOK FIRAZYR. FIR0725 FOLLOW UP INFOR FROM REPORTER: "PATIENT ALSO NOTED, ¿¿DOES IT MATTER THAT I ALREADY TOOK OFF THE NEEDLE AND RECAPPED THE SYRINGE? I¿M NOT SURE IF IT WAS THE SYRINGE OR THE NEEDLE THAT CAUSED THE ISSUE TO BE FAIR. I HAVE BOTH PARTS STILL.¿

  Patient problems: Alteration in Body Temperature; Dizziness; Nausea; Pain; Swelling/ Edema; Unspecified Gastrointestinal Problem

  MAUDE report 19058902 ↗
• InjuryMar 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD HYPOINT¿ HAD STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WORK AT BIOGEN AND AM WORKING ON A COMPLAINT THAT WE RECEIVED REGARDING A BD NEEDLE USED WITH THE AVONEX PEN. THE COMPLAINT ISSUE WAS REGARDING THE STERILITY OF THE NEEDLE, WHICH CAUSED A SERIOUS ADVERSE EVENT. I HAVE PUT THE EXACT COMPLAINT DESCRIPTION BELOW. I AM LOOKING TO HAVE THE NEEDLE LOT INVESTIGATED, OR THE DOCUMENTATION REVIEWED TO ENSURE THAT IT WAS MANUFACTURED AND STERILIZED ACCORDING TO SPECIFICATIONS, WITH RESULTS PROVIDED IN A REPORT. THE BD NEEDLE LOT IS 1105352. IS THIS SOMETHING THAT YOU CAN HELP WITH?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881664 ↗
• MalfunctionAug 11, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICATION WOULD NOT PUSH THROUGH THE NEEDLE. PATIENT STATED SHE INITIALLY THOUGHT SHE MIGHT HAVE HIT SCAR TISSUE. SHE REMOVED THE NEEDLE AND TRIED PUSHING MEDICATION BUT IT WOULD STILL NOT FLOW THROUGH THE NEEDLE AFTER APPLYING A GOOD AMOUNT OF PRESSURE AND FORCE. PATIENT USED A DIFFERENT DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509038 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED WHILE USING BD HYPOINT¿ HYPODERMIC NEEDLE THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT STATED THAT, THE ICATIBANT SYRINGES TIP WAS BROKEN AND THEREFORE HE WAS NOT ABLE TO INJECT ANY MEDICATION OR USE THE SYRINGE AT ALL. UNKNOWN IF MISSED DOSE OR ADVERSE EVENTS. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED BY INTAKE CENTER, IT IS UNKNOWN WHEN THE NEEDLE WAS BROKEN AND IT IS UNKNOWN IF THE PRODUCT WAS DROPPED OR HANDLED ROUGHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076104 ↗
• MalfunctionMay 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CATALOG NUMBER OF THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS LISTED AS 300253 ON THE COC, WHILE IT WAS LISTED AS 3002535 ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CONFIRMATION IS REQUIRED ON THE HIGHLIGHTED NUMBER MENTIONED IN THE IMAGE I.E., ¿3002535¿. IS THIS IS THE CATALOGUE NUMBER OR NOT? IF THIS IS THE CATALOGUE NUMBER, THEN IT IS NOT MATCHING WITH THE REQUIREMENT OF SPECIFICATION AND COC (CATALOGUE NUMBER IN SPECIFICATION AND VENDOR COC IS ¿300253¿)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015223 ↗
• MalfunctionDec 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT COMMENTED THAT SHE WAS AFFECTED BY ABDOMINAL EDEMA WITH SEVERE PAIN AND CONTINUED TO APPLY THE MEDICATION FIRAZYR ICATIBANT PREFILLED SYRINGE AS USUAL. HE SAYS THAT HE HAS APPLIED IT FOR YEARS AND NEVER HAD A PROBLEM. THIS TIME, SHE SAYS THAT THE SYRINGE WAS FAULTY SINCE THE MEDICATION SPILLED OUT OF THE SYRINGE AND WHEN THE PLUNGER WAS PRESSED, AIR ENTERED IT. SHE COMMENTS THAT AT THAT MOMENT SHE BECAME VERY NERVOUS, SHE HAD ANOTHER DOSE AND IT WAS APPLIED CORRECTLY. OF THE DOSE THAT COMMENTS ON THE FAILURE, IT SAYS THAT NONE OF THE PRODUCT COULD BE APPLIED. THE PATIENT REPORTED WITH SOME DOUBTS, TO ENSURE THE INFORMATION TO BE AS ACCURATE AS POSSIBLE IN THE REPORT, I ASKED HER IF THE MEDICATION FLOWED THROUGH THE PLUNGER PART OF THE SYRINGE OR THROUGH THE CONNECTION BETWEEN THE SYRINGE AND THE NEEDLE AND SHE ANSWERED "AT THAT MOMENT I GOT VERY NERVOUS, NOW YOU MAKE ME DOUBT BUT I THINK IT WAS BY THE PLUNGER PART¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018755 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD HYPOINT¿ HYPODERMIC NEEDLE THE NEEDLE PULLED OUT OF THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT STATED THE NEEDLE FELL AFTER HE ATTACHED IT TO THE SYRINGE. HE STATED THE NEEDLE DID SCREW INTO THE SYRINGE BUT WHEN HE TOOK OFF THE NEEDLE TOP IT FELL. PATIENT STATED THAT THE NEEDLE ATTACHED TO THE SYRINGE JUST FINE WITH NO ISSUES, BUT THEN ALL OF A SUDDEN THE NEEDLE JUST FELL OFF. CLARIFICATION PROVIDED, THE ORANGE NEEDLE HUB STAYED ON THE SYRINGE HOWEVER THE CLEAR PIECE THAT HOLDS THE NEEDLE DISCONNECTED FROM THE ORANGE PART, AND THE NEEDLE AND CLEAR PART FELL OFF. HE TRIED TO RECONNECT BUT IT WOULDN'T HOLD. HE DID NOT MISS A DOSE AS HE HAD ANOTHER NEEDLE TO USE. HE WAS ABLE TO OBTAIN ANOTHER NEEDLE FROM CVS SO HE IS NOT MISSING A NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748204 ↗
• MalfunctionOct 7, 2022Break; Break

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE BROKE IN THE AVONEX PEN. THIS OCCURRED ONCE EACH IN LOTS 1013936 AND 1013938. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER REGARDING THAT THE NEEDLE WAS BROKEN IN AN AVONEX PEN. ACCORDING TO THE PATIENT AND THE NURSE, THERE WAS NO OTHER PIECE OF NEEDLE TO BE FOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563974 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE BROKE OFF WHILE ATTEMPTED TO INJECT FIRAZYR 30MG DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT INFORMED THAT THEY WENT TO INFUSE THERE FIRAZYR 30MG PFS AND THE NEEDLE BROKE AS THEY WENT TO INJECT. NO INJURY TO PATIENT. THEY THEN PUT THIS INTO THE SHARPS BIN AND USED THEIR SPARE FIRAZYR 30MG PFS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236969 ↗
• MalfunctionApr 25, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS BLOCKED DURING THE ICATIBANT INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WITH HAE CARRIES ICATIBANT INJECTIONS FOR EMERGENCY TREATMENT. PATIENT REQUIRED THIS TREATMENT AND INJECTED HIMSELF WITH THE MEDICATION AS A SUBCUTANEOUS INJECTION. HOWEVER THE PATIENT WAS UNABLE TO ADMINISTER THE MEDICATION DUE TO A NEEDLE DEFECT. THE PATIENT ATTENDED OUR UNIT FOR TREATMENT THAT WAS REQUIRED. IT WAS NOTED THERE WAS NO ISSUE WITH THE PRE-FILLED SYRINGE ONLY THE NEEDLE. TH NEEDLE DID ALLOW FOR THE MEDICATION TO BE GIVEN. ON THE UNIT WE WERE ABLE TO CHANGE THE NEEDLE AND GIVE THE MEDICATION AS PRESCRIBED. AS THIS IS AN EMERGENCY TREATMENT IT IS VITAL PATIENTS HAVE ACCESS TO THIS TREATMENT URGENTLY IF THEY NEED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197766 ↗
• MalfunctionAug 13, 2021Leak/Splash; Material Twisted/Bent; Leak/Splash; Material Twisted/Bent

  IT WAS REPORTED HYPOINT NDL25GA5/8IN LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CUSTOMER WHO IS AN EXPERIENCED USER OF THE PRODUCT HAS INJECTED WITH THIS NEEDLE ON (B)(6) 2021 AT 12:15 P.M. SOME OF THE SOLUTION LEAKED, DEFECTIVE SYRINGE AND NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321980 ↗
• MalfunctionAug 5, 2021Calcified; Packaging Problem; Calcified; Packaging Problem

  IT WAS REPORTED THAT HYPOINT NDL25GA5/8IN PACKAGE WAS DAMAGED AND THE LABEL WAS UNREADABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CHECKING THE CONSIGNMENT WE HAVE OBSERVED THAT 9 BOX'S RECEIVED, 1 BOX RECEIVED IN DAMAGED CONDITION AND MATERIAL EXPOSED TO ENVIRONMENT. WE HAVE NOT RECEIVED COA WITH CONSIGNMENT. DURING MATERIAL CHECKING ALL CONTAINER LABEL NOT READABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284422 ↗
• MalfunctionJun 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WHITE "STAIN" WAS FOUND AT THE BASE OF THE BD HYPOINT¿ HYPODERMIC NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE LOOKED DIRTY." "WHITE ´STAIN´ IN THE BASE OF THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084257 ↗
• MalfunctionJun 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HYPOINT NDL25GA5/8IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICLES OBSERVED ON NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020287 ↗
• MalfunctionMar 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE HYPOINT NDL25GA5/8IN EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 300253 BATCH NO: UNKNOWN WHEN TRYING TO ADMINISTER, PATIENT INJECTED THE NEEDLE AND THE FIRAZYR PRODUCT LEAKED OUT AND WENT ALL OVER THE PATIENT AND ALL OVER THE FLOOR. PATIENT REPORTED ¿BECAUSE THERE WAS NO ACTUAL SEAL IN THE SCREW ON, THE SOLUTION LEAKED ALL AROUND.¿ ONLY A TINY BIT OF PRODUCT WENT INTO THE PATIENT BEFORE THE NEEDLE DISLODGED AND THE PRODUCT LEAKED THROUGH. PATIENT ALSO REPORTED HAE (HEREDITARY ANGIOEDEMA) SYMPTOMS OF NAUSEA (ALMOST VOMITED), BLOATING, GASTROINTESTINAL PAIN, AND HEARTBURN ON (B)(6)-2021. SHE SELF-ADMINISTERED FIRAZYR AT 2:36 PM AND IT IMMEDIATELY WAS EFFECTIVE RELIEF FOR HER NAUSEA, ALL OF HER OTHER SYMPTOMS WERE RESOLVED WITHIN ONE HOUR OF ADMINISTRATION.SAME LOT AND EXPIRY DATE FOR BOTH EVENTS. NO ADDITIONAL INFORMATION AVAILABLE. PATIENT CONFIRMED THAT SHE WAS OK AND THAT THE PACKAGING WAS NOT TAMPERED WITH. ¿I JUST WENT AND I LAID DOWN AND STAYED QUITE AND WENT TO BED AND I SEEM TO BE OK RIGHT NOW.¿ PATIENT EXPLAINED VIA PHONE CALL THAT SHE ATTACHED THE NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458189 ↗
• MalfunctionMar 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE HYPOINT NDL25GA5/8IN EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 300253 BATCH NO: UNKNOWN PATIENT REPORTED VIA PHONE CALL DEFECTIVE DOSE OF FIRAZYR. ON SATURDAY ((B)(6)2021) EVENING, PATIENT WAS FEELING LIKE SHE NEEDED TO TAKE A SECOND DOSE OF FIRAZYR. WHEN TRYING TO ADMINISTER, PATIENT INJECTED THE NEEDLE AND THE FIRAZYR PRODUCT LEAKED OUT AND WENT ALL OVER THE PATIENT AND ALL OVER THE FLOOR. PATIENT REPORTED ¿BECAUSE THERE WAS NO ACTUAL SEAL IN THE SCREW ON, THE SOLUTION LEAKED ALL AROUND.¿ ONLY A TINY BIT OF PRODUCT WENT INTO THE PATIENT BEFORE THE NEEDLE DISLODGED AND THE PRODUCT LEAKED THROUGH. PATIENT CONFIRMED THAT SHE WAS OK AND THAT THE PACKAGING WAS NOT TAMPERED WITH. ¿I JUST WENT AND I LAID DOWN AND STAYED QUITE AND WENT TO BED AND I SEEM TO BE OK RIGHT NOW.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453009 ↗
• MalfunctionDec 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT "WHITE PAINT" WAS FOUND ALONG THE BASE OF THE BD HYPOINT¿ HYPODERMIC NEEDLE WHEN IT WAS OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN LOOKING AT THE NEEDLE IN THE FIRST KIT I OPENED, THE NEEDLE HAD SOME WHITE PAINT ALONG THE BASE AND UP THE INSIDE OF IT ON ONE PART, SO I DIDN'T USE THIS NEEDLE AND PUT IT ASIDE". "PATIENT REPORTED THAT INDEED THAT THERE WAS SOME WHITE PAINT AROUND THE BASE WHERE THE NEEDLE IS ATTACHED TO THE SYRINGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11098367 ↗