BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8461984 · Received March 28, 2019

    Report

    Report Number
    9616657-2019-00163
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 7, 2019
    Report Date
    March 13, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT FOR CLOG ON LOT # 8171657. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 32G 4MM BD PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED (USED). CONSUMER REPORTED NEEDLE IN BOX THAT WOULD NOT WORK DURING INJECTION. THE RETURNED SAMPLE WAS EXAMINED AND EXHIBITED A BENT NON-PATIENT END CANNULA. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - THE BENT NEEDLE ON THE NON-PATIENT END OF THE CANNULA WOULD BE THE CAUSE FOR NO MEDICATION FLOWING THROUGH, HENCE THE CUSTOMER WOULD THINK THE NEEDLE WAS CLOGGED (AS REPORTED). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE POSSIBLE ROOT CAUSE FOR THIS ISSUE (BENT NON-PATIENT END 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 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 WHEN FITTED TO THE PEN. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED AN INABILITY TO DELIVER INSULIN DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: IT WAS REPORTED: THAT THE CONSUMER FOUND A 3RD NEEDLE IN BOX THAT WOULD NOT WORK DURING INJECTION AND 2 OTHER DID NOT PRIME. VERBATIM: ITEM 320122 LOT 8171657 EXP 2023-07-31. JUST FOUND A 3RD NEEDLE IN BOX THAT WOULD NOT WORK DURING INJECTION TODAY. FOUND 2 OTHER DID NOT PRIME UNKNOWN OCCUDATE THE NON PATIENT END LOOKS STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255734 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8171657 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other