BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 8838952 · Received July 29, 2019

    Report

    Report Number
    9616657-2019-00282
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED 32G X 4MM BD PEN NEEDLE. CONSUMER STATED SHE THINKS A NEEDLE BROKE OFF IN HER KNEE. THE SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE PATIENT END (PE) CANNULA WAS HOOKED, AND THE NON-PATIENT END (NPE) CANNULA WAS BROKEN. NO EVIDENCE OF MANUFACTURING DEFECTS WERE OBSERVED ON THE SAMPLE. AS THE SAMPLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE FOR THESE ISSUES (HOOKED PE CANNULA AND BROKEN NPE CANNULA) IS HUMAN ERROR DURING USE OF THE PEN NEEDLE. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (HOOKED PE CANNULA, BROKEN NPE CANNULA) THE POSSIBLE ROOT CAUSE FOR THESE ISSUES (HOOKED PE CANNULA AND BROKEN NPE CANNULA) IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED CANNULA BREAKAGE DURING USE, RESULTING IN PATIENT SEEKING MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320122 BATCH NO.: 8348565 VERBATIM: CONSUMER STATED SHE THINKS A NEEDLE BROKE OFF IN HER KNEE. STATED SHE HAD A SCHEDULED APPOINTMENT FOR BLOOD WORK AT HOSPITAL, (UNRELATED TO NEEDLE BREAK), SO SHE HAD THEM TAKE AN X-RAY WHILE SHE WAS THERE TO CHECK FOR THE NEEDLE. X-RAY DONE. STATED, NO NEEDLE WAS FOUND ON X-RAY. STATED NEEDLE COULD HAVE BROKEN OFF ONTO FLOOR. STATED SHE ALWAYS PRIMES BEFORE USE, SO SHE'S CERTAIN THE NEEDLE WAS THERE. STATED SAW A LITTLE BLOOD AFTER INJECTION, RUBBED HER LEG BECAUSE SHE WAS HAVING PAIN AND THAT'S WHEN SHE NOTICED THE NEEDLE WAS MISSING. STATED SHE DID GET HER COMPLETE DOSAGE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED CANNULA BREAKAGE DURING USE, RESULTING IN PATIENT SEEKING MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320122, BATCH NO.: 8348565. VERBATIM: CONSUMER STATED SHE THINKS A NEEDLE BROKE OFF IN HER KNEE. STATED SHE HAD A SCHEDULED APPOINTMENT FOR BLOOD WORK AT HOSPITAL, (UNRELATED TO NEEDLE BREAK), SO SHE HAD THEM TAKE AN X-RAY WHILE SHE WAS THERE TO CHECK FOR THE NEEDLE. X-RAY DONE. STATED, NO NEEDLE WAS FOUND ON X-RAY. STATED NEEDLE COULD HAVE BROKEN OFF ONTO FLOOR. STATED SHE ALWAYS PRIMES BEFORE USE, SO SHE'S CERTAIN THE NEEDLE WAS THERE. STATED SAW A LITTLE BLOOD AFTER INJECTION, RUBBED HER LEG BECAUSE SHE WAS HAVING PAIN AND THAT'S WHEN SHE NOTICED THE NEEDLE WAS MISSING. STATED SHE DID GET HER COMPLETE DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633560 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8348565 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other