BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 12017582 · Received June 17, 2021

    Report

    Report Number
    9616656-2021-00687
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-06-16. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF (B)(4) UNOPENED PEN NEEDLES WITH TEAR DROP LABELS IDENTIFYING THEM AS 4MM, (B)(4) GAUGE PEN NEEDLES FROM LOT 0253602. (B)(4) OF THE RETURNED SAMPLES WERE INSPECTED TO ENSURE THAT USING THEM WAS AS LEAST HARMFUL AS INTENDED. THE OUTER DIAMETERS OF THESE NEEDLES WERE MEASURED, THE RESULTS OF WHICH ARE FEATURED BELOW: 1. 0.0090 IN. 2. 0.0093 IN. 3. 0.0092 IN. 4. 0.0093 IN. 5. 0.0093 IN. 6. 0.0092 IN. 7. 0.0092 IN. 8. 0.0092 IN. 9. 0.0092 IN. 10. 0.0091 IN. 11. 0.0092 IN. 12. 0.0092 IN. 13. 0.0091 IN. 14. 0.0092 IN. 15. 0.0092 IN. 16. 0.0093 IN. 17. 0.0094 IN. 18. 0.0091 IN. 19. 0.0091 IN. 20. 0.0092 IN. 21. 0.0091 IN. 22. 0.0092 IN. 23. 0.0092 IN. 24. 0.0093 IN. 25. 0.0091 IN. 26. 0.0092 IN. 27. 0.0091 IN. 28. 0.0090 IN. 29. 0.0093 IN. 30. 0.0092 IN. ALL OF THE NEEDLES WERE MEASURED WITHIN ACCEPTABLE OUTER DIAMETERS FOR (B)(4) GAUGE NEEDLES (0.0090 IN TO 0.0095 IN). THE INTEGRITY OF EACH NEEDLE POINT WAS INSPECTED AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF ANY OF THE NEEDLES. LASTLY, FLOUR WAS APPLIED TO THE NEEDLES¿ CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED. THE NEEDLES WERE WITHIN SPECIFICATIONS AND DID NOT FEATURE ANY DULLNESS, BURRS, OR OTHER DEFECTS. THE PEN NEEDLES WERE TESTED FOR LEAKS/CLOGS VIA SIMULATED USE. THE PEN NEEDLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. THE PEN WAS PRIMED AND SALINE WAS PUSHED THROUGH THE SYSTEM. THE SALINE EXITED THE PEN NEEDLES WITHOUT ANY ISSUES. AFTER SWITCHING ONE PEN NEEDLE FOR ANOTHER SEVERAL TIMES, IT WAS NOTED THAT SALINE COULD LEAK FROM THE DISTAL TIP OF THE NEEDLE. SALINE WOULD GATHER AT THE TIP AND FORM A BEAD WITHOUT INPUT. IT IS BELIEVED THAT THIS IS THE RESULT OF RESIDUAL PRESSURE IN THE SYSTEM FORCING OUT A MINUTE AMOUNT OF SOLUTION. LEAKING WOULD NOT OCCUR ANYWHERE ELSE IN THE SYSTEM. THE LEAK WOULD STOP AS PRESSURE WAS NORMALIZED IN THE SYSTEM. NO PROBLEMS FOUND DIRECTLY WITH ANY OF THE RETURNED PEN NEEDLES REGARDING LEAKS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP EXPERIENCED LEAKAGE, AND WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320550, BATCH NO: 0253602. I HAVE BEEN USING BD NANO NEEDLES FOR QUITE SOME TIME WITHOUT REALLY ANY PROBLEMS TO REPORT. AT LEAST THAT GOES FOR THE 1ST GENERATION. WHEN I LAST FILLED MY RX I WAS GIVEN THE 2ND GENERATION AND HAVE HAD SEVERAL PROBLEMS. I AM ON THE SECOND BOX, AND HAVE EXPERIENCED PROBLEMS WITH BOTH BOXES. THIS INCLUDES NEEDLES THAT AREN'T SHARP AND WON'T PENETRATE THE SKIN, BENT NEEDLES, CLOGS ( I GUESS - THE INSULIN WON'T GO IN VERY WELL, BUT LEAKS OUT WHEN I PULL THE NEEDLE OUT). THIS IS MAKING IT DIFFICULT TO REALLY KNOW HOW MUCH INSULIN IS GOING IN. I AM CONSIDERING ASKING FOR DIFFERENT ONES NEXT TIME I NEED PEN NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. INVESTIGATION CONCLUSION: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 0253602 FOR DIFFICULT/UNABLE TO OPERATE. THIS IS THE 1ST. RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE ON LOT# 0253602. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT# 0253602 FOR LEAKAGE. THIS IS THE 1ST. RELATED COMPLAINT FOR LEAKAGE ON LOT# 0253602. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT# 0253602 FOR NEEDLE CLOG. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT# 0253602. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP EXPERIENCED LEAKAGE, AND WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320550. BATCH NO: 0253602. I HAVE BEEN USING BD NANO NEEDLES FOR QUITE SOME TIME WITHOUT REALLY ANY PROBLEMS TO REPORT. AT LEAST THAT GOES FOR THE 1ST GENERATION. WHEN I LAST FILLED MY RX I WAS GIVEN THE 2ND GENERATION AND HAVE HAD SEVERAL PROBLEMS. I AM ON THE SECOND BOX, AND HAVE EXPERIENCED PROBLEMS WITH BOTH BOXES. THIS INCLUDES NEEDLES THAT AREN'T SHARP AND WON'T PENETRATE THE SKIN, BENT NEEDLES, CLOGS ( I GUESS - THE INSULIN WON'T GO IN VERY WELL, BUT LEAKS OUT WHEN I PULL THE NEEDLE OUT). THIS IS MAKING IT DIFFICULT TO REALLY KNOW HOW MUCH INSULIN IS GOING IN. I AM CONSIDERING ASKING FOR DIFFERENT ONES NEXT TIME I NEED PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914965 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0253602 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1