BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGES

    MDR report key: 12861844 · Received November 23, 2021

    Report

    Report Number
    1920898-2021-01235
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 23, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1130878. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2026. H.4. DEVICE MANUFACTURE DATE: 5/10/2021. D.4. MEDICAL DEVICE LOT #: 1144191. D.4. MEDICAL DEVICE EXPIRATION DATE: 6/30/2026. H.4. DEVICE MANUFACTURE DATE: 5/24/2021. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/7/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (5) 0.5ML BD INSULIN SYRINGES FROM LOT# 1130878 AND (2) 0.5ML BD INSULIN SYRINGES FROM LOT# 1144191. THE CUSTOMER REPORTED THAT THE NEEDLE SHIELDS WERE HARD TO REMOVE, AND WHEN REMOVED THE WHOLE NEEDLE HUB GOES WITH THE SHIELD. THE SAMPLES FROM LOT# 1130878 WERE EXAMINED, AND IT WAS OBSERVED THAT 2 SYRINGES EXHIBITED A DETACHED NEEDLE HUB/SHIELD ASSEMBLY; NO DAMAGE WAS OBSERVED ON THE BARREL TIPS. THE REMAINING 3 SYRINGES WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCE. ALL 3 TESTED SYRINGES FELL WITHIN SPECIFICATION, AND NO HUB SEPARATION WAS OBSERVED. THE SAMPLES FROM LOT# 1144191 WERE EXAMINED, AND IT WAS OBSERVED THAT BOTH SYRINGES EXHIBITED A DETACHED NEEDLE HUB/SHIELD ASSEMBLY; NO DAMAGE WAS OBSERVED ON THE BARREL TIPS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# (B)(6). ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# (B)(6). ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE REMOVING SHIELD OF A BD ULTRA-FINE¿ INSULIN SYRINGES THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:  IT WAS REPORTED BY THE CONSUMER, THE NEEDLE HUB SEPARATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE REMOVING SHIELD OF A BD ULTRA-FINE¿ INSULIN SYRINGES THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:  IT WAS REPORTED BY THE CONSUMER, THE NEEDLE HUB SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760505 BD ULTRA-FINE¿ INSULIN SYRINGES PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 SEE H.10 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown