BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 8883202 · Received August 12, 2019

    Report

    Report Number
    9616656-2019-00737
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED FIVE (5) SEALED 30G X 5MM BD AUTOSHIELD DUO PEN NEEDLES FROM LOT 8319886; NO SAMPLES FROM LOT 8241571 WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE NEEDLES ARE DIFFICULT TO USE ON ELDERLY PATIENTS, THEY ARE TOO STIFF RESULTING IN THE STAFF HAVING TO PUSH DOWN CAUSING THE RESIDENT DISCOMFORT AND MAKING IT DIFFICULT FOR STAFF TO ENSURE INSULIN DOSE HAS BEEN GIVEN. WHEN THE AUTO SHIELD NEEDLE IS WITHDRAWN FROM INJECTION SITE ¿FLUID¿ IS ON THE SKIN. ALL FIVE RETURNED SAMPLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL FIVE PEN NEEDLES WERE ABLE TO EXPEL PROPERLY, AND NO ISSUES WERE OBSERVED. AFTER BEING TESTED FOR FLOW, EACH SAMPLE WAS TESTED FOR SAFETY-SHIELD ACTIVATION: ALL FIVE PEN NEEDLES HAD THEIR SAFETY-SHIELD MECHANISMS ACTIVATE PROPERLY AFTER A SIMULATED INJECTION, AND NO ISSUES WERE OBSERVED. AS NO MANUFACTURING DEFECTS OR ISSUES WERE OBSERVED ON THE FIVE RETURNED SAMPLES, THE ALLEGED ISSUES COULD NOT BE CONFIRMED. 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. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES FOR THE PROVIDED SAMPLES. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.4. MEDICAL DEVICE LOT #: SEE H.10. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8241571. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-09-30. H.4. DEVICE MANUFACTURE DATE: 2018-08-29. D.4. MEDICAL DEVICE LOT #: 8319886. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. H.4. DEVICE MANUFACTURE DATE: 2018-11-15 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM EXPERIENCED DIFFICULTY OPERATING OR NOT WORKING/FUNCTIONING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329505 BATCH NO.: 8241571. VERBATIM: THE CONCERN: JULY 17 ¿ THESE NEEDLES ARE NOT EASY TO USE ON OUR FRAIL ELDERLY RESIDENTS. TOO STIFF AND HAVE TO PUSH DOWN CAUSING THE RESIDENT DISCOMFORT. NOT EASY FOR THE NURSE TO ENSURE INSULIN DOSE HAS BEEN GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM EXPERIENCED DIFFICULTY OPERATING OR NOT WORKING/FUNCTIONING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329505 BATCH NO.: 8241571. VERBATIM: THE CONCERN: JULY 17 ¿ THESE NEEDLES ARE NOT EASY TO USE ON OUR FRAIL ELDERLY RESIDENTS. TOO STIFF AND HAVE TO PUSH DOWN CAUSING THE RESIDENT DISCOMFORT. NOT EASY FOR THE NURSE TO ENSURE INSULIN DOSE HAS BEEN GIVEN.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30G X 5MM EXPERIENCED DIFFICULTY OPERATING OR NOT WORKING/FUNCTIONING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329505, BATCH NO.: 8241571. VERBATIM: THE CONCERN: JULY 17 ¿ THESE NEEDLES ARE NOT EASY TO USE ON OUR FRAIL ELDERLY RESIDENTS. TOO STIFF AND HAVE TO PUSH DOWN CAUSING THE RESIDENT DISCOMFORT. NOT EASY FOR THE NURSE TO ENSURE INSULIN DOSE HAS BEEN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676725 PEN NEEDLE AUTOSHIELD DUO 30GX5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other