BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8874299 · Received August 8, 2019

    Report

    Report Number
    9616657-2019-00304
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 16, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (80) 32G X 4MM BD PEN NEEDLES WITH TEAR DROP LABELS REMOVED; SEPARATED TEAR DROP LABELS FROM LOTS: 7095662, 7264658, 7319668, 8015511, 8015847, 8047593, AND 8163911 WERE PROVIDED. CONSUMER REPORTED MISSING NEEDLE ON NPE, BENT NEEDLE NPE, SHORTER NEEDLE NPE, AND SHE REPORTED NOTHING COMES OUT DURING INJECTION. ALL 80 RETURNED SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 30 PEN NEEDLES WITH BROKEN NON-PATIENT END (NPE) CANNULAS. 48 PEN NEEDLES WITH BENT NPE CANNULAS. 2 PEN NEEDLES WITH STRAIGHT NPE CANNULAS; THESE TWO WERE TESTED FOR FLOW USING A TEST PEN INJECTOR AND BOTH PEN NEEDLES WERE ABLE TO EXPEL PROPERLY NO EVIDENCE OF MANUFACTURING DEFECTS WAS OBSERVED ON THE SAMPLES WITH EITHER BENT OR BROKEN NPE CANNULAS, AND SINCE ALL 80 SAMPLES WERE RETURNED AFTER USE, THE LIKELY CAUSE OF THE BENT OR BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. FURTHERMORE, SINCE NO MANUFACTURING ISSUES WERE OBSERVED, THE ALLEGED ISSUES REGARDING MISSING NPE CANNULA OR NPE CANNULA DIMENSION COULD NOT BE CONFIRMED. THE BENT OR BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS 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 (BENT NPE CANNULA, BROKEN NPE CANNULA). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (MISSING NPE CANNULA, DIMENSION NPE CANNULA). THE POSSIBLE ROOT CAUSE FOR THESE ISSUES (NPE CANNULA BENT; NPE CANNULA BROKEN) 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HAS BEEN FOUND UNABLE TO DELVER INSULIN DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE WAS MISSING AND BENT ON THE NPE. ADDITIONALLY, IT WAS REPORTED THE NEEDLE WAS SHORTER ON THE NPE AND NOTHING COMES OUT DURING INJECTION. CONSUMER REPORTED MISSING NEEDLE ON NPE, BENT NEEDLE NPE, SHORTER NEEDLE NPE, AND SHE REPORTED NOTHING COMES OUT DURING INJECTION. SHE WASN'T VISUALLY TESTING THE NEEDLE IN THE PAST, BUT NOW SHE HAS BEEN VISUALLY TESTING THE NEEDLE TO SEE IF IT IS THERE AND IF IT IS STRAIGHT ON BOTH END. INCIDENT DATE-UNKNOWN; OCCURRENCE-UNKNOWN; ITEM#: 320122; LOT#: 8354700; EXPIRATION DATE: 2024-01-31; 2ND BOX ITEM#: 320122; LOT#: 8163911. EXPIRATION DATE: 06-30-2023. SHE DOES THE PRIMING, SHE USES THE NEW PEN NEEDLE EACH TIME OF HER INJECTION. SHE USES THE INSULIN 4 TIMES A DAY. SHE ROTATES THE INJECTION SITE. SHE DOES NOT TIGHTEN THE PEN NEEDLE. THESE ISSUES HAVE HAPPENED WITH DIFFERENT BOXES AS WELL WITH NANO NEEDLE. BOX DISCARDED AND LOT#:, INCIDENT DATE-OCCURRENCE, UNKNOWN. SHE HAS SAVED ABOUT 100 OF THE SAMPLES. SHE IS NOT SURE WHICH BOXES THEY CAME FROM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8354700. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-03-01. MEDICAL DEVICE LOT #: 8163911. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-06-12. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HAS BEEN FOUND UNABLE TO DELVER INSULIN DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE WAS MISSING AND BENT ON THE NPE. ADDITIONALLY, IT WAS REPORTED THE NEEDLE WAS SHORTER ON THE NPE AND NOTHING COMES OUT DURING INJECTION. VERBATIM: CONSUMER REPORTED MISSING NEEDLE ON NPE, BENT NEEDLE NPE, SHORTER NEEDLE NPE, AND SHE REPORTED NOTHING COMES OUT DURING INJECTION. SHE WASN'T VISUALLY TESTING THE NEEDLE IN THE PAST, BUT NOW SHE HAS BEEN VISUALLY TESTING THE NEEDLE TO SEE IF IT IS THERE AND IF IT IS STRAIGHT ON BOTH END. INCIDENT DATE- UNKNOWN; OCCURRENCE- UNKNOWN; ITEM# 320122; LOT# 8354700; EXPIRATION DATE- 2024-01-31; 2ND BOX-ITEM# 320122; LOT# 8163911. EXPIRATION DATE- 06-30-2023. SHE DOES THE PRIMING, SHE USES THE NEW PEN NEEDLE EACH TIME OF HER INJECTION. SHE USES THE INSULIN 4 TIMES A DAY. SHE ROTATES THE INJECTION SITE. SHE DOES NOT TIGHTEN THE PEN NEEDLE. THESE ISSUES HAVE HAPPENED WITH DIFFERENT BOXES AS WELL WITH NANO NEEDLE. BOX DISCARDED AND LOT#, INCIDENT DATE- OCCURRENCE -UNKNOWN. SHE HAS SAVED ABOUT 100 OF THE SAMPLES. SHE IS NOT SURE WHICH BOXES THEY CAME FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669728 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other