BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9186625 · Received October 14, 2019

    Report

    Report Number
    9616656-2019-00982
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 28, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (15) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT NOTHING COMES OUT DURING PRIMING, SHE CANNOT PUSH THE PLUNGER, AND IT HURTS. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 2 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA AND 3 SAMPLES EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA, WHICH COULD CAUSE TO NOT FLOW THROUGH THE CANNULA PROPERLY. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. ALL SAMPLES WERE ALSO TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿-0.0095¿). 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 SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT AND BROKEN NON PATIENT END OF THE CANNULA). 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING MEDICATION DOES NOT FLOW AND THE PLUNGER IS DIFFICULT TO MOVE WITH A BD ULTRA FINE¿ PEN NEEDLES. THE DIFFICULTY IN PRIMING OCCURRED ON 13 SEPARATE OCCASIONS WITH BATCH 9071866, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NOTHING COMES OUT DURING THE PRIMING, THE CONSUMER CANNOT PUSH THE PLUNGER IT HURTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9071866. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-12. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN." 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 DURING PRIMING MEDICATION DOES NOT FLOW AND THE PLUNGER IS DIFFICULT TO MOVE WITH A BD ULTRA FINE¿ PEN NEEDLES. THE DIFFICULTY IN PRIMING OCCURRED ON 13 SEPARATE OCCASIONS WITH BATCH 9071866, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NOTHING COMES OUT DURING THE PRIMING, THE CONSUMER CANNOT PUSH THE PLUNGER IT HURTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983665 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other