BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 11872427 · Received May 24, 2021

    Report

    Report Number
    9616656-2021-00582
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 8, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/24/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (5) OPENED 32GX4MM BD PEN NEEDLES FROM LOT# 0133297. THE CUSTOMER REPORTED 10 PEN PEN NEEDLES THAT CLOGGED, ONE WITH THE NEEDLE MISSING WHEN THE COVER WAS REMOVED, ALSO, ONE PEN NEEDLE WITH THE PATIENT END BENT. ALL 5 RETURNED SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 4 PEN NEEDLES WITH A BENT NON-PATIENT END (NPE) CANNULA 2 PEN NEEDLES WITH A BENT PATIENT END (PE) CANNULA 1 PEN NEEDLE WITH A STRAIGHT PE AND NPE CANNULA DUE TO THE CONDITION OF THE NPE CANNULA ON 4 RETURNED SAMPLES ONLY 1 PEN NEEDLE COULD BE TESTED FOR FLOW; THE 1 PEN NEEDLE WITH A STRAIGHT PE AND NPE CANNULA WAS TESTED FOR FLOW USING A TEST PEN INJECTOR, AND WAS ABLE TO EXPEL PROPERLY. NO DEFECTS WERE OBSERVED. NONE OF THE RETURNED PEN NEEDLES EXHIBITED A MISSING NEEDLE. THE BENT NPE CANNULAS COULD HAVE LED TO THE CUSTOMER THINKING THAT A NEEDLE WAS MISSING. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE ALL 5 SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE (CLOG) IS UNCONFIRMED. THE ROOT CAUSE FOR THE BENT NEEDLE IS USER RELATED. THE NPE CANNULAS WERE BENT DUE TO IMPROPER HANDLING OF THE PEN NEEDLES BY THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 PEN NDL 32G 4MM HP WERE UNABLE OR DIFFICULT TO PRIME, AND CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320550 BATCH NO: 0133297 CONSUMER REPORTED FINDING 10 PEN NEEDLES CLOG DURING FLOW CHECK. OF THESE, 10 WERE FOUND CLOGGED WHILE OUT FOR DINNER AND HAD ONLY ONE PEN NEEDLE. RESULTING COULD NOT EAT. OCCD: (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 10 PEN NDL 32G 4MM HP WERE UNABLE OR DIFFICULT TO PRIME, AND CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320550 BATCH NO: 0133297. CONSUMER REPORTED FINDING 10 PEN NEEDLES CLOG DURING FLOW CHECK. OF THESE, 10 WERE FOUND CLOGGED WHILE OUT FOR DINNER AND HAD ONLY ONE PEN NEEDLE. RESULTING COULD NOT EAT. OCCD: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768081 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0133297 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1