BD Integra 305272Recalls & reported problems
Becton, Dickinson And Company · SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB · Class 2
Quick summary
This BD Integra 3 ml syringe with a detachable needle is used for injections. Most of its 71 reports describe the needle pulling out of the hub or flying off during use, the plunger tip poking through the rubber, and medication leaking or splashing out; a few mention the needle breaking off and staying in the patient. Nine reports describe injuries and no deaths. No recalls name this device, and no reports were filed in the past12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00382903052721), received between Nov 27, 2017 and Oct 30, 2024 — classified as 9 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (21 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.
Reports received per month
Most reported problems
Device problems
- Retraction Problem21
- Leak/Splash20
- Break13
- Difficult or Delayed Activation12
- Detachment of Device or Device Component4
- Material Separation4
- Detachment Of Device Component2
- Burst Container or Vessel1
Patient problems
- No Known Impact Or Consequence To Patient33
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient8
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient3
- Needle Stick/Puncture2
- Underdose2
- Injury1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
MATERIAL#: 305272, BATCH#: 1110062. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT: REF (B)(4) AND LOT 1110062 FOR THE INJECTION. ISSUE: DR SUSPECTED NEEDLE SEPARATED FROM DEVICE, SUSPECTS NEEDLE MIGHT HAVE BE LODGED IN PT. MED INFO CONFIRMED THAT THE DEVICE DOES RETRACT. ADMINISTERED TESTOSTERONE. PT HARM: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571568 ↗MalfunctionFeb 26, 2024Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784009 ↗MalfunctionAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT NEEDLE ON THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE APPEARS TO BE DEFECTIVE. VERBATIM: DIRECT CONSUMER REPORTS NEEDLE APPEARS TO BE DEFECTIVE. SYRINGE BROKE OFF DURING USE. REPORTS NO HARM CAUSED. WHICH PART OF THE SYRINGE WAS BROKEN DURING USE? NEEDLE FELL OUT OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455425 ↗MalfunctionFeb 15, 2023Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash
IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE WAS CLOGGED AND THAT CAUSED A LEAK OUT THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT WHEN THEY ARE INJECTING THE MEDICATION, IT IS COMING BACK UP THROUGH THE PLUNGER INSTEAD OF GOING THROUGH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16382313 ↗MalfunctionJan 19, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS FOREIGN MATTER FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ASPIRATING MEDICINE WITH A READY-TO-USE STERILE SYRINGE ON THE OPERATING TABLE, AFTER REMOVING THE NEEDLE CAP, THE STERILE NEEDLE IS FOUND WRAPPED IN PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16211189 ↗MalfunctionJan 6, 2023Loose or Intermittent Connection; Material Separation; Loose or Intermittent Connection; Material Separation
IT WAS REPORTED THAT THE NEEDLE "FLEW" OUT OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE HUB WHEN PUSHING ON IT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I ACTUALLY HAD ANOTHER FAILURE YESTERDAY. THERE WAS MEDICAL LEFT IN THE SYRINGE AND I PUSH IT OUT AND THE NEEDLE FLEW OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16117532 ↗MalfunctionNov 15, 2022Break; Break
IT WAS REPORTED THAT AT LEAST 3 BD SYRINGE INTEGRA 3ML W/NDL EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE METAL PIN PUSHING THE RUBBER PLUNGER HAS BROKEN THROUGH THE PLUNGER AT LEAST 3 TIMES WHILE USING THIS SYRINGE. IT HAPPENS WHEN I GAVE MYSELF A TESTOSTERONE INJECTION AND WHEN MY WIFE GAVE ME AN INJECTION. I TOLD THE PHARMACY AND THEY SAID PUSH THE SYRINGE SLOWER. THAT HAS NOT HELPED. I WORRIED MAY INJECT A FOREIGN MATERIAL IN MY MADE WITH THE SYRINGE BREAKING AND ALSO CONCERNED THAT I'M NOT GETTING THE CORRECT DOSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15801061 ↗InjurySep 23, 2022Break; Break
IT WAS REPORTED WHILE USING A BD SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB AN ADVERSE EVENT WITHOUT PRODUCT MALFUNCTION LED TO THE USER VISITING THE HOSPITAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE RETRACTED AT THE END OF INJECTION AND THOUGHT IT BROKE IN SITE. CALLER WENT TO URGENT CARE THEY INFORMED CALLER TO VISIT LOCAL EMERGENCY ROOM. THE EMERGENCY ROOM COMPLETED ULTRA SOUND AND XRAY. DID NOT LOCATE THE NEEDLE. CALLER TOOK THE SYRINGE APART AS I WAS SPEAKING AND FOUND THE NEEDLE AND WAS SATISFIED.
Patient problems: Foreign Body In Patient
MAUDE report 15470260 ↗MalfunctionSep 17, 2022Break; Break
IT WAS REPORTED WHILE USING BD INTEGRA¿ THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SECOND ISSUE WAS THAT WHEN HE PULLED THE NEEDLE OUT THE NEEDLE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15442975 ↗MalfunctionSep 17, 2022Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD INTEGRA¿ THE PLUNGER BROKE THE STOPPER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING THE BD INTEGRA SYRINGE 3MIL 22GAUGE 1.5", THE PLUNGER BROKE THROUGH THE STOPPER BEFORE ALL THE MEDICINE WAS FULLY INJECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15442973 ↗MalfunctionAug 9, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING 2 BD INTEGRA¿ 3 ML SYRINGES THEY DETACHED DURING USE. CONSUMER SAID HE IS STILL CONCERNED ABOUT THE NEEDLE. HE DID NOT SEEK MEDICAL ATTENTION, NO PAIN OR DISCOMFORT. CONSUMER INFORMED OF DEMOGRAPHICS STATED NOT IN ANY PAIN. NEVER COMPLETED THE XRAYS. INFORMED THIS CALLER OF THE FUNCTION OF THIS SYRINGE AND THE RETRACTING NEEDLES. CALLER NOW FEELS THE NEEDLE RETRACTED IN THE WAY IT SHOULD HAVE NOW KNOWING THIS INFORMATION. TWO NEEDLES DETACHED FROM SYRINGE, GOT STUCK IN PATIENT'S "REAR END" - PATIENT IS GOING TO URGENT CARE FOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191012 ↗MalfunctionAug 9, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED WHILE USING 2 BD INTEGRA¿ 3 ML SYRINGES THEY DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER SAID HE IS STILL CONCERNED ABOUT THE NEEDLE. HE DID NOT SEEK MEDICAL ATTENTION, NO PAIN OR DISCOMFORT. CONSUMER INFORMED OF DEMOGRAPHICS STATED NOT IN ANY PAIN. NEVER COMPLETED THE XRAYS. INFORMED THIS CALLER OF THE FUNCTION OF THIS SYRINGE AND THE RETRACTING NEEDLES. CALLER NOW FEELS THE NEEDLE RETRACTED IN THE WAY IT SHOULD HAVE NOW KNOWING THIS INFORMATION. TWO NEEDLES DETACHED FROM SYRINGE, GOT STUCK IN PATIENT'S "REAR END" - PATIENT IS GOING TO URGENT CARE FOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191011 ↗MalfunctionJun 24, 2022Break; Break
IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE 3ML W/NDL 22X1-1/2 RB BROKE DURING USE. THE FOLLOWING INFORMATION WAS COMPLETED BY THE INITIAL REPORTER: CUSTOMER CALLED IN REGARDS OF THE 3ML SYRINGE AND STATED THAT IT BROKE DURING USE. NO HARM TO CUSTOMER, HOWEVER WENT AND GOT AN X-RAY DONE TO MAKE SURE NEEDLE WAS NOT STUCK INSIDE.
Patient problems: Needle Stick/Puncture
MAUDE report 14809889 ↗InjuryAug 18, 2021Break; Break
IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED HEARD A POPPING NOISE, AND THEN NEEDLE HUB SNAPPED AND NEEDLE BROKE OFF IN CONSUMERS REAR END (UPPER RIGHT QUADRANT). VERBATIM: CONSUMER STATED HER HUSBAND WAS GIVING HER A PROGESTERONE INJECTION HEARD A POPPING NOISE, AND THEN NEEDLE HUB SNAPPED AND NEEDLE BROKE OFF IN CONSUMERS REAR END (UPPER RIGHT QUADRANT). CONSUMER REPORTED SHE WENT TO THE EMERGENCY ROOM, HAD X-RAYS TAKEN, DOCTOR WAS UNABLE TO CONFIRM NEEDLE LOCATION. CONSUMER STATED DOCTOR DISMANTLED PRODUCT BUT COULD NOT FIND NEEDLE IN SYRINGE; CONSUMER TOOK SYRINGE HOME, WILL BE SENDING IN FOR EVALUATION. CONSUMER STATED SHE DOES NOT WANT A PRODUCT REPLACEMENT; DOES NOT FEEL COMFORTABLE USING PRODUCT ANY LONGER. CONSUMER STATED SHE WAS UPSET SHE WAS FORCED TO JEOPARDIZE FUTURE PREGNANCY BY UNDERGOING AN X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 12337775 ↗MalfunctionJul 28, 2021Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation
IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB LEAKED AND HAD THE NEEDLE RETRACT PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT WHILE ADMINISTERING MEDICATION TO PATIENT, NEEDLE RETRACTED PRIOR TO FINISHING THE INJECTION. IT WAS ALSO REPORTED THAT WHILE GIVING ANOTHER INJECTION, MEDICINE LEAKED OUT OF WHERE THE SYRINGE AND NEEDLE ATTACH.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12236156 ↗MalfunctionJul 6, 2021Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation
IT WAS REPORTED THAT THE DETACHABLE NEEDLE IN THE BD INTEGRA¿ SYRINGE WAS LOOSE AND FAILED TO COMPLETELY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE'VE RECEIVED A FEW REPORTS OF FAULTY NEEDLE RETRACTION WITH THE BD INTEGRA SYRINGE (3 ML 22G X 1 ½). AFFECTED LOT# 1029959, EXP 2026-01-31. PER REPORTS, WE'VE HEARD OF THE NEEDLES FALLING OUT, OF NEEDLES NOT FULLY RETRACTING, AND OTHERS WHERE IT SEEMS TO BE FUNCTIONING AS INTENDED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12125489 ↗MalfunctionApr 16, 2021Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB NEEDLE COLLAPSED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305272 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE NEEDLE COLLAPSED INSIDE THE SYRINGE. VERBATIM: CONSUMER REPORTED WHILE INJECTING TESTOSTERONE WITH ONE SYRINGE THE NEEDLE "COLLAPSED" INSIDE THE SYRINGE. CONSUMER REPORTED WHILE PLACING AIR INTO VIAL OF TESTOSTERONE WITH 2 OTHER SYRINGES THE NEEDLE COLLAPSED INTO THE SYRINGE. INFORMED CONSUMER OF THE FUNCTION OF THIS RETRACTING SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11680431 ↗MalfunctionMar 31, 2021Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT THE DETACHABLE NEEDLE FAILED TO RETRACT INTO THE BD INTEGRA¿ SYRINGE. THIS OCCURRED 5 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE NOT RETRACTING REPORTED ISSUE - SYRINGE NOT RETRACTING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11599146 ↗MalfunctionMar 11, 2021Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB NEEDLE RETRACTED PREMATURELY. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE TRATRACTED PREMATURELY. NEEDLE RETRACTED SPONTANEOUSLY WHILE ADMINISTERING MEDICATION MEANING THAT NOT ALL OF THE MEDICATION COULD BE ADMINISTERED. HAS HAPPENED ON SEVERAL OCCASIONS OVER THE LAST COUPLE OF WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11468220 ↗InjuryDec 4, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE DETACHABLE NEEDLE BROKE OFF OF THE BD INTEGRA" SYRINGE DURING USE AND REMAINED IN THE PATIENT'S BUTTOCKS. THE PATIENT WENT TO THE ER AND HAD AN X-RAY PERFORMED, BUT THE BROKEN NEEDLE WAS NOT FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED --CALLER STATED USED INTEGRA SYRINGE WITH NEEDLE BREAK OFF IN THE BUTTOCKS. CONSUMER WENT TO ER (EMERGENCY ROOM). THE ER COMPLETED AN XRAY AND COULD NOT LOCATE THE NEEDLE. THEY THEN TOOK THE SYRINGE APART TO LOOK FOR THE NEEDLE IN SYRINGE AND STILL COULD NOT FIND IT."
Patient problems: Needle Stick/Puncture
MAUDE report 10946794 ↗InjuryDec 4, 2020Break; Break
IT WAS REPORTED THAT THE DETACHABLE NEEDLE BROKE OFF FROM THE BD INTEGRA¿ SYRINGE INTO THE CONSUMER'S BUTTOCKS WHILE INJECTING TESTOSTERONE. THE CONSUMER VISITED THE EMERGENCY ROOM AND AN X-RAY WAS TAKEN, BUT THE BROKEN NEEDLE PIECE WAS NOT FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, HE THINKS NEEDLE BROKE OFF IN HIM WHEN HIS WIFE WAS ADMINISTERING HIS TESTOSTERONE INJECTION. STATED, SPENT OVER 2 HOURS IN EMERGENCY ROOM. STATED, X-RAY TAKEN AND THEY WERE NOT ABLE TO LOCATE A NEEDLE INSIDE HIS BUTTOCKS. STATED, HE WAS NEVER TOLD HOW TO USE SYRINGE BY HIS PHARMACIST OR DOCTOR CONSUMER STATED, HE AND HIS WIFE ARE ELDERLY AND CANNOT AFFORD OUT OF POCKET ON GOING TO EMERGENCY ROOM. I EXPLAINED, THERE IS NOT GUARANTEE BUT HE CAN SUBMIT OUT OF POCKET AND EOB'S, (EXPLANATION OF BENEFITS) TO MANAGEMENT FOR CONSIDERATION. I EXPLAINED, THE PRODUCT IS A RETRACTABLE SAFETY SYRINGE".
Patient problems: Foreign Body In Patient
MAUDE report 10946706 ↗MalfunctionNov 26, 2020Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305272, BATCH NO: 9142823. IT WAS REPORTED THAT THE NEEDLE HAS NEVER RETRACTED AFTER THE INJECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10909576 ↗MalfunctionNov 5, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 3 BD INTEGRA" 3 ML SYRINGES WITH DETACHABLE NEEDLES EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE AND CONSUMER REPORTED DURING THE LAST 3 INJECTIONS THE MEDICATION HAS LEAKED OUT OF THE SYRINGES ALL OVER THE CONSUMER. STATED IT'S WHERE THE NEEDLE IS THREADED INTO THE SYRINGE THAT LEAKS MEDICATION. STATED THE PHARMACY PROVIDED THE SYRINGES IN A CLEAR BAG, UNABLE TO PROVIDE LOT #. LOT # UNKNOWN CAT # 305272. DATE OF EVENT: (B)(6) 2020.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10796348 ↗MalfunctionJun 2, 2020Leak/Splash
IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE PLUNGER ROD BROKE ON 3 SEPARATE OCCASIONS DURING USE. IN THE 1ST INCIDENT, THE CONSUMER WAS INJECTING TESTOSTERONE WHEN "ABOUT HALFWAY THROUGH", THE PLUNGER MADE A "POPPING" SOUND AND "INSTANTLY" DEPRESSED THE REMAINDER OF THE WAY IN. THE CONSUMER WAS UNCERTAIN WHAT HAPPENED TO THE REMAINING ".5 ML" OF DRUG. ON THE 2ND OCCURRENCE, IT WAS REPORTED THAT THE PLUNGER "FLEW OUT OF THE SYRINGE", AND ON THE 3RD OCCURRENCE, THE PLUNGER DEPRESSED "TO THE BOTTOM". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER IS REPORTING WHEN TAKING TESTOSTERONE INJECTIONS ON 3 OCCASSIONS, HE HEARD A "POPPING SOUND" THE FIRST TIME HE HEARD, HE WAS DISPENSING AND HALFWAY THRU, HE HEARD THE "POP" AND HE IS NOT SURE ALL OF THE MEDICATION WAS DISPENSED THE SECOND TIME IT HAPPENED, THE "PLUNGER FLEW OUT OF THE SYRINGE" THE THIRD TIME, THE PLUNGER "WENT TO THE BOTTOM" CONSUMER USED THE WORDS "TODAY" WHICH WOULD REPRESENT (B)(6) 2020, WHEN LETTER WAS WRITTEN." I¿VE BEEN USING SYRINGES MADE BY BD FOR ABOUT THREE YEARS FOR WEEKLY TESTOSTERO
Patient problems: Underdose
MAUDE report 10112757 ↗MalfunctionJun 2, 2020Leak/Splash
IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE WAS BEING USED TO INJECT TESTOSTERONE WHEN A "POPPING SOUND" WAS HEARD, AND THE PLUNGER "INSTANTLY" DEPRESSED TO THE BOTTOM. THE CONSUMER FOUND THE REMAINING DRUG IN THE NECK OF THE PLUNGER AND LEAKING FROM THE TOP. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER IS REPORTING WHEN TAKING TESTOSTERONE INJECTIONS ON 3 OCCASSIONS, HE HEARD A "POPPING SOUND" THE FIRST TIME HE HEARD, HE WAS DISPENSING AND HALFWAY THRU, HE HEARD THE "POP" AND HE IS NOT SURE ALL OF THE MEDICATION WAS DISPENSED THE SECOND TIME IT HAPPENED, THE "PLUNGER FLEW OUT OF THE SYRINGE" THE THIRD TIME, THE PLUNGER "WENT TO THE BOTTOM" CONSUMER USED THE WORDS "TODAY" WHICH WOULD REPRESENT (B)(6) 2020, WHEN LETTER WAS WRITTEN." I¿VE BEEN USING SYRINGES MADE BY BD FOR ABOUT THREE YEARS FOR WEEKLY TESTOSTERONE INJECTIONS. I¿VE NEVER HAD ANY ISSUES WITH YOUR SYRINGES UNTIL THE LAST FEW WEEKS. SOMETHING CHANGED IN EITHER DESIGN OR MANUFACTURING AND IT IS NOT GOOD. I¿VE PICKED UP NEW REFILL OF BD INTEGRA SYRINGES WITH RETRACTING BD PRECISION GLIDE NEEDLE (3ML 2G
Patient problems: Underdose
MAUDE report 10112689 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.