BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11547800 · Received March 22, 2021

    Report

    Report Number
    9616656-2021-00301
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 27, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 PEN NDL 32G 4MM HP 100 BOX 1200 US WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLES HAVE BEEN FAILING AT A HIGH RATE. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 11:35:27: CONSUMER CONFIRMED LOT, 0106047 STATED, WHEN PRIMING HIS 2 UNITS, NOTHING COMES OUT. STATED, IF HE TRIES TO PRIME THE SAME PEN NEEDLE A SECOND TIME, THE PEN LOCKS UP. WENT OVER INSTRUCTION ON HOW TO ATTACH AND PRIME. STATED, HE HAD 1 PEN NEEDLE TODAY FROM THE SAME LOT THAT DID NOT PRIME. CL EMAIL RECEIVED (B)(6) 2021 14:11:53 PRODUCT NAME OR NUMBER (6 DIGIT THAT STARTS WITH 32) 32G5/32 LOT # 0103047 REASON FOR CALL UNACCEPTABLE NUMBER OF NEEDLES THAT WERE UNUSABLE (THROWN AWAY) EMAIL RECEIVED (B)(6) 2021 13:06:24MY BD NANO 2ND GEN PEN NEEDLES HAVE BEEN FAILING AT A RATE HIGHER THAN ACCEPTABLE. I HAVE EASILY NOT BEEN ABLE TO USE OVER 10% OF THIS BOX! TOO EXPENSIVE FOR THIS MANY THROWN AWAY."

    Additional Manufacturer Narrative · 1

    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 WAS REPORTED THAT 3 PEN NDL 32G 4MM HP 100 BOX 1200 US WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLES HAVE BEEN FAILING AT A HIGH RATE. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 11:35:27: CONSUMER CONFIRMED LOT, 0106047. STATED, WHEN PRIMING HIS 2 UNITS, NOTHING COMES OUT. STATED, IF HE TRIES TO PRIME THE SAME PEN NEEDLE A SECOND TIME, THE PEN LOCKS UP. WENT OVER INSTRUCTION ON HOW TO ATTACH AND PRIME. STATED, HE HAD 1 PEN NEEDLE TODAY FROM THE SAME LOT THAT DID NOT PRIME. CL. EMAIL RECEIVED (B)(6) 2021 14:11:53. PRODUCT NAME OR NUMBER (6 DIGIT THAT STARTS WITH 32) 32G5/32. LOT # 0103047. REASON FOR CALL UNACCEPTABLE NUMBER OF NEEDLES THAT WERE UNUSABLE (THROWN AWAY). EMAIL RECEIVED (B)(6) 2021 13:06:24MY BD NANO 2ND GEN PEN NEEDLES HAVE BEEN FAILING AT A RATE HIGHER THAN ACCEPTABLE. I HAVE EASILY NOT BEEN ABLE TO USE OVER 10% OF THIS BOX! TOO EXPENSIVE FOR THIS MANY THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437209 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0106047 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1