BD Hypoint™ 300255Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00382903002559), received between Oct 17, 2017 and Apr 19, 2023 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Delivered as Unsterile Product; Material Puncture/Hole; Delivered as Unsterile Product; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE PIERCED THROUGH THE SHIELD IN THE PACKAGING UNIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY NOTED NEEDLE OF RECORMON 4000IU IS PRICKED THROUGH THE NEEDLE CAP UPON OPENING OF BLISTER AND BEFORE USE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773330 ↗
• MalfunctionDec 28, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE BD HYPOINT¿ NEEDLE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BOX CONTAINS BLACK FOREIGN MATTER INSIDE ONE NEEDLE SHIELD. THE DEFECT WAS FOUND AFTER OPENING THE PRODUCT FOLDING BOX AND THE CUSTOMER DID NOT USE THE CONCERNED BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062983 ↗
• MalfunctionAug 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 19 BD HYPOINT¿ NEEDLES LEAKED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOSPITAL REPORTED THAT THERE WAS LEAKAGE DURING INJECTION, AND THE FILLING LIQUID WAS SODIUM HYALURONATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191155 ↗
• MalfunctionMay 12, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS BLOCKED WHEN ATTEMPTING TO ADMINISTER RECORMON TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NURSE... ATTEMPTED TO ADMINISTER IV RECORMON 4000IU TO PATIENT VIA PERIPHERAL CANNULA BUT WAS UNABLE TO DELIVER THE MEDICATION DESPITE GOOD PATENCY OF THE CANNULA. SHE ALSO ATTEMPTED TO SYRINGE OUT THE RECORMON FROM THE ORIGINAL GLASS SYRINGE, BUT UNABLE TO ASPIRATE. SHE TOOK A NEW SYRINGE AND MANAGED TO ADMINISTER WITH NO ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14378144 ↗
• MalfunctionMar 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BD HYPOINT¿ NEEDLE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THE SOLUTION DIPPED INTO THE CAP...".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690298 ↗
• MalfunctionJul 30, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE CONTAINER WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PHARMACIST REPORTED AN ISSUE REGARDING RECORMON PFS 5000IU, H0711H07. THE PHARMACIST FOUND THAT NEEDLE CONTAINERS OF THE BATCH HAVE AN APPEARANCE DEFECT, THE NEEDLE CONTAINERS LOOK SLIGHTLY YELLOW THAN OTHER BATCHES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256352 ↗
• MalfunctionApr 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT HYPOINT NDL27GA1/2IN NEEDLE SEPARATED FROM THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WAS SEPARATED FROM BARREL DURING USING ON MARKET. CUSTOMER TESTED THE PFS AND NEEDLE FROM THE SAME BATCHES, THE SAME ISSUE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704354 ↗
• MalfunctionFeb 15, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND ON THE BD HYPOINT¿ HYPODERMIC NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿A DISPENSER REPORTED THAT SOME WHITE SUBSTANCE WAS OBSERVED ON THE NEEDLE OF A RECORMON PFS."

  Patient problems: No Patient Involvement

  MAUDE report 11326659 ↗
• MalfunctionJan 20, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A HYPOINT NDL27GA1/2IN HAD THE NEEDLE POINT PENETRATE THOUGH THE SHIELD BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "NEEDLE PIERCED THROUGH NEEDLE CONTAINER. ON (B)(6) 2020, A QA RESPONSIBLE PERSON WAS INFORMED BY TERRITORY MANAGER REGARDING A PRODUCT COMPLAINT ON RECORMON 5000 IU BATCH NO. H0704H01. THE COMPLAINT CAME FROM THE NAKORNPING HOSPITAL, CHIANG MAI, THAILAND. A BENT NEEDLE PIERCING A NEEDLE CONTAINER WAS FOUND CO-PACKED IN THE ROCHE DRUG PRODUCT. THE CO-PACKED NEEDLE WAS NOT OPENED AND WAS KEPT IN THE ORIGINAL PACKAGE (SEE PICTURES BELOW). THE LOT NUMBER OF DEFECTIVE NEEDLE IS LOT 9155564, EXP 2024-06-30. AFTER CONFIRMING WITH COMPLAINANT, THE RESPECTIVE BATCH OF RECORMON 5000 IU WAS ADMINISTERED TO THE PATIENT USING ANOTHER NEW NEEDLE, THE DEFECTIVE NEEDLE WAS NOT USED. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN AND THE COMPLAINANT REQUESTS THE INVESTIGATION OUTCOME. AS ADDITIONAL INFORMATION, THE IMPACTED BATCH WAS ALREADY REPORTED IN ¿A BENT NEEDLE¿ COMPLAINT IN (B)(6) 2020, BUT THE NEEDLE CONTAINER WAS NOT PIERCING THE NEEDLE CONTAINER.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205971 ↗
• MalfunctionDec 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE HYPOINT NDL27GA1/2IN EXPERIENCED A LOOSE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR HAS RECEIVED A COMPLAINT FROM THE END USER REPORTING ISSUE THE PRODUCT NEORECORMON STATING THE FOLLOWING: ¿NEEDLE IS VERY LOOSE AND DETACHES ITSELF FROM THE SYRINGE WHEN THE CAP IS REMOVED.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10962356 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT HYPOINT NDL27GA1/2IN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO INFORM YOU REGARDING A COMPLAINT FROM AN END USER STATING THAT THE NEEDLE IS BROKEN AND THE FRONT PART IS INSIDE THE CAP.

  Patient problems: No Patient Involvement

  MAUDE report 10512504 ↗
• MalfunctionJul 27, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS FOUND STICKING THROUGH THE BOX BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿A PATIENT'S EMPLOYEE PURCHASED 3 UNITS OF THE PRODUCT AT THE PHARMACY NEAR HIS HOME, WHICH WERE IMMEDIATELY REFRIGERATED. AT THE TIME OF TAKING ONE OF THEM FOR PATIENT ADMINISTRATION, HIS WIFE STATES THAT SHE OBSERVED THAT THE NEEDLE HAD PIERCED THE BOX, AND IT LOOKED LIKE IT WAS STICKING OUT OF THE SECONDARY PACKAGING. THE PRODUCT WAS NOT USED, THERE WAS NO CONTACT WITH THE PATIENT.¿

  Patient problems: No Patient Involvement

  MAUDE report 10330213 ↗
• InjuryMay 12, 2020Break; Break

  IT WAS REPORTED THAT HYPOINT NDL27GA1/2IN NEEDLE BROKE DURING INJECTION. THIS COULD LEAD TO PATIENT INJURY OR THE PATIENT NOT RECEIVING REQUIRED DOSE ON TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLE TIP. A HOSPITAL PHARMACIST REPORTED THAT A PATIENT BROUGHT A DEFECTIVE PRODUCT AND ASKED FOR REPLACEMENT. THE PHARMACIST SAID THIS PRODUCT WAS SOLD TO THE PATIENT BY THE HOSPITAL. WHEN THE PATIENT CAME TO THE HOSPITAL, THE PATIENT CLAIMED THE NEEDLE WAS BROKEN WHILE PERFORMING INJECTION BY HIMSELF. THEN, THE PATIENT CHANGED A NEW NEEDLE (UNKNOWN SOURCE) AND PERFORMED INJECTION AGAIN. THE DETAILED INFORMATION REGARDING THE INJECTION PROCESS COULD NOT BE CONFIRMED. THE NEEDLE WAS BROKEN DURING INJECTION; THIS ISSUE COULD HAVE LED TO PATIENT INJURY OR THE PATIENT COULD NOT HAVE RECEIVED THE REQUIRED DOSE ON TIME. IT HAS A POTENTIAL RISK TO PATIENT SAFETY, SO AFFILIATE REPORTS THIS CASE AS A POTENTIAL CRITICAL COMPLAINT. A FULL INVESTIGATION IS REQUIRED FOR THIS COMPLAINT SINCE THE NURSE WAS INJURED. THIS COMPLAINT IS CONSIDERED POTENTIAL CRITICAL.

  Patient problems: Injury

  MAUDE report 10049897 ↗
• MalfunctionMay 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT HYPOINT NDL27GA1/2IN PUNCTURED THROUGH THE NEEDLE CAP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED A COMPLAINT FROM THE END USER REPORTING ISSUE THE PRODUCT NEORECORMON. RECORMON 2000IU WAS PREPARED BY A HCP TO ONE OF THE DIALYSIS PATIENT PRIOR 5 MINUTES OF CLOSING TREATMENT. THE HCP WANTED TO OPEN THE SEAL FROM THE NEEDLE AND SHE FELT THE PAIN SENSATION FROM HER RIGHT INDEX FINGER. OBSERVED THAT THE NEEDLE PUNCTURED THROUGH THE NEEDLE CAP. THE HCP DISCARDED THE WHOLE NEEDLE AND TAKE ANOTHER NEEDLE GAUGE 25 AS REPLACEMENT. IV RECORMON 2000IU WAS GIVEN TO PATIENT. THIS INCIDENT HAS CAUSED AN AE (NEEDLE PRICK INJURY TO THE HCP).

  Patient problems: Needle Stick/Puncture

  MAUDE report 10031195 ↗
• MalfunctionMar 2, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE THE NEEDLE SHIELD WAS DISCOVERED TO BE BROKEN AND NEEDLE WAS EXPOSED THUS AFFECTING STERILITY WITH A BD HYPOINT¿ NDL27GA1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECT FOUND, ITS NEEDLE CONTAINER WAS BROKEN BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9774248 ↗
• MalfunctionJan 27, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT BD HYPOINT¿ HYPODERMIC NEEDLE PIERCED THROUGH THE SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A HOSPITAL REPORTED THAT A NURSE FOUND A DEFECT WITH RECORMON PFS. THE NURSE OPENED THE BLISTER AND FOUND THE NEEDLE PASSED THROUGH THE UNOPENED NEEDLE CONTAINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634678 ↗
• MalfunctionFeb 13, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD HYPOINT¿ HYPODERMIC NEEDLE HAD FOREIGN MATTER INSIDE OF THE NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336212 ↗
• MalfunctionFeb 6, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD HYPOINT¿ HYPODERMIC NEEDLE HAD INCORRECT LABEL INFORMATION. THERE ARE TWO LABELS WITH TWO DIFFERENT BATCH NUMBERS, 8255230 AND 8255229. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8311155 ↗
• MalfunctionJan 10, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND NEAR THE EPOXY AND ON THE NEEDLE HUB OF THE BD HYPOINT¿ HYPODERMIC NEEDLES AFTER REMOVING THEIR NEEDLE SHIELDS. LOT #S 7051492 AND 7075224 RESPECTIVELY WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT THE NUMBER OF OCCURRENCES FOR EACH IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8237059 ↗
• MalfunctionJan 10, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT A BD HYPOINT¿ HYPODERMIC NEEDLE WAS LEAKING BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233344 ↗
• MalfunctionDec 3, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD HYPOINT¿ HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125343 ↗
• MalfunctionDec 3, 2018Leak/Splash; Microbial Contamination of Device

  IT WAS REPORTED THAT BD HYPOINT HYPODERMIC NEEDLE LEAKED DUE TO A MOLDING DEFECT BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125270 ↗
• MalfunctionNov 13, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD HYPOINT¿ HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8065769 ↗
• MalfunctionFeb 20, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USE OF THE BD HYPOINT¿ HYPODERMIC NEEDLE THE "HEALTH WORKER FOUND ONE THREADLIKE FOREIGN MATTER INSIDE OF THE NEEDLE SHIELD WHEN HE REMOVED THE LID LABEL. HE ALSO FOUND ONE FIBER ON THE HUB." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7283893 ↗
• MalfunctionFeb 6, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USE OF THE BD HYPOINT¿ HYPODERMIC NEEDLE THE HEALTH CARE WORKER FOUND FOREIGN MATTER ON THE NEEDLES BEFORE INJECTION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244825 ↗