BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10299982 · Received July 20, 2020

    Report

    Report Number
    9616656-2020-00694
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 30, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 31 JULY 2020 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.COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVALUATION? YES. D.10 RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (34) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 9191534. CUSTOMER STATES THAT WHEN ATTACHING SOME PEN NEEDLES TO HIS INSULIN PEN THEY DON'T WORK OR RELEASE INSULIN. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 32 OUT OF 34 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA PROPERLY. BOTH REMAINING SYRINGES WERE EXAMINED AND BOTH 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 THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATION. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NON PATIENT END OF THE CANNULA). ROOT CAUSE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9191534. CONSUMER REPORTED WHEN ATTACHING SOME PEN NEEDLES TO HIS INSULIN PEN THEY DON'T WORK OR RELEASE INSULIN. CONSUMER DOES NOT PRIME BEFORE INJECTIONS, STATED HE WAS NEVER TOLD TO DO THAT. ADVISED OF THE IMPORTANCE OF PRIMING BEFORE EVERY INJECTION. DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:(B)(6) BATCH NO: 9191534 CONSUMER REPORTED WHEN ATTACHING SOME PEN NEEDLES TO HIS INSULIN PEN THEY DON'T WORK OR RELEASE INSULIN. CONSUMER DOES NOT PRIME BEFORE INJECTIONS, STATED HE WAS NEVER TOLD TO DO THAT. ADVISED OF THE IMPORTANCE OF PRIMING BEFORE EVERY INJECTION. DATE OF EVENT: UNKNOWN.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9191534. CONSUMER REPORTED WHEN ATTACHING SOME PEN NEEDLES TO HIS INSULIN PEN THEY DON'T WORK OR RELEASE INSULIN. CONSUMER DOES NOT PRIME BEFORE INJECTIONS, STATED HE WAS NEVER TOLD TO DO THAT. ADVISED OF THE IMPORTANCE OF PRIMING BEFORE EVERY INJECTION. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758029 BD ULTRA FINE PEN NEEDLES PEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 9191534 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other