BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9309139 · Received November 12, 2019

    Report

    Report Number
    9616656-2019-01104
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 25, 2019
    Report Date
    December 10, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (30) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 9046859, (11) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 8107700, (20) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 8247891, (3) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 8030726, AND (9) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 8158528. CUSTOMER STATES THAT THE PATIENT END IS BENDING AND THE PEN NEEDLE CLOGS DURING INJECTION. ALL RETURNED SAMPLES WERE EXAMINED AND 27 OUT OF 30 SAMPLES FROM LOT # 9046859, ALL 11 SAMPLES FROM LOT # 8107700, 15 OUT OF 20 SAMPLES FROM LOT # 8247891, ALL 3 SAMPLES FROM LOT # 8030726, AND 7 OUT OF 9 SAMPLES FROM LOT # 8158528 EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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. 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

    Description of Event or Problem · 0

    MATERIAL NO. 320122 BATCH NO. 9046859 & UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLES PATIENT END IS BENDING AND THE PEN NEEDLE CLOGS DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INJECTION CLOGS FINDING THE PEN NEEDLES PATIENT END BENDS THEN IT CLOGS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9046859. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-02-15. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 320122 BATCH NO. 9046859 & UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLES PATIENT END IS BENDING AND THE PEN NEEDLE CLOGS DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INJECTION CLOGS FINDING THE PEN NEEDLES PATIENT END BENDS THEN IT CLOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103238 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other