BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 13040063 · Received December 18, 2021

    Report

    Report Number
    1920898-2021-01317
    Event Type
    Malfunction
    Date Received
    December 18, 2021
    Date of Event
    November 20, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT #: 6011607 ¿ DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: 02/03/2016. LOT #: 5313863 ¿ DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: 01/19/2016. LOT #: 6179910 ¿ DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: 08/12/2016. LOT #: 5047756 ¿ DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: 04/07/2015. LOT #: 5271566 ¿ DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: 12/11/2015. LOT #: 1318949 ¿ DEVICE EXPIRATION DATE UNKNOWN; DEVICE MANUFACTURE DATE: 01/10/2012. INVESTIGATION SUMMARY: EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED FOR ALL THE LOT #S LISTED IN ITEM 3. BELOW AND THESE ARE THE 1ST RELATED COMPLAINTS FOR LABEL INFORMATION MISSING (EXPIRATION DATE) ON THESE LOT #S. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THESE LOT #S CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW FOR LOT #S 6011607, 5313863, 6179910, 5047756, 5271566 AND 1318949 WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 19 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLES HAD LABEL INFORMATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED BOXES OF UNUSED PRODUCT WITH NO EXPIRY DATE ON BOXES AS PER FOLLOWING LOT #S: 6011607 - 4 BOXES, 5313863 - 3 BOXES, 6179910 - 3 BOXES, 5047756 - 3 BOXES, 5271566 - 2 BOXES, 1318949 - 1 BOX. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932634 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown