BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 1/2IN UF

    MDR report key: 9832740 · Received March 14, 2020

    Report

    Report Number
    1920898-2020-00253
    Event Type
    Malfunction
    Date Received
    March 14, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 5, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908431033
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT FOR NEEDLE SHIELD DOES NOT DETACH AS INTENDED AND THE 2ND RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9112598. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9112598. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGE 0.3ML 30GA 1/2IN UF EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328431 BATCH NO. 9112598. VERBATIM: ITEM 328431, LOT # 9112598, LETTER RECEIVED FROM PET OWNER. I AM CONTACTING YOU TO EXPRESS A CONCERN IN QUALITY OF INSULIN SYRINGES, 12.7, 3/10ML, 1/2"X30G PURCHASED IN JANUARY AT A DISTRIBUTOR. I USE THESE SYRINGES FOR MY DIABETIC DOG. I HAVE USED THEM FOR OVER ONE AND A HALF YEARS. PREVIOUSLY, THE DISTRIBUTOR WAS ORDERING A CHEAP QUALITY SYRINGE FROM KOREA. I REQUESTED A BETTER QUALITY BECAUSE THOSE SYRINGES WOULD BREAK EASILY. YOUR BD SYRINGES ARE DOUBLE THE COST OF THE CHEAP QUALITY ONES. THIS IS THE FIRST BOX I HAVE HAD ISSUES WITH. THE ORANGE CAP ON A GOOD 8 SYRINGES WAS STUCK. ON 3 SYRINGES WHEN I PULLED OFF THE ORANGE CAP THE WHOLE HEAD OF THE SYRINGE CAME OFF. I JUST FELT YOUR COMPANY NEEDED TO KNOW THAT THIS BATCH WAS NOT WELL MADE. LOT #: 9112598, CATALOG#: 328431, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296535 SYRINGE 0.3ML 30GA 1/2IN UF PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328431 9112598 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other