BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 21021075 · Received December 26, 2024

    Report

    Report Number
    9614033-2024-00088
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    November 6, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046577
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 4193530 AND OTHER EXPIRATION DATE INCLUDES 2029-06-30. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-07-11.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DISTRIBUTOR MEDWATCH REPORT NUMBER ADDED: 1423395-2024-00506. ADDITIONAL EVENT DETAILS WERE ALSO FOUND IN THEIR SUBMISSION THAT WAS NOT SHARED WITH BD "IT WAS REPORTED THAT THE SYRINGE "KEPT SPLITTING DOWN THE SIDE UPON INJECTION." DUE TO THIS, "TECH GOT BLOOD IN HER EYE".TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR (B)(4) ON (B)(6)2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE.IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED." INVESTIGATION RESULTS: TWO (2) PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ONE PHOTO SHOWS 7, 10ML SYRINGES OUTSIDE OF THEIR PRIMARY PACKAGING. THE OTHER PHOTO SHOWS A 10ML SYRINGE WITH LIQUID INSIDE; HOWEVER, IT IS NOT POSSIBLE TO SEE A CRACK IN THE PHOTO. SINCE THE FAILURE COULD NOT BE OBSERVED IN EITHER PHOTO, THE REPORTED INCIDENT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED AS THE FAILURE WAS NOT VERIFIED.

    Description of Event or Problem · 0

    MATERIAL# 304657. BATCH# 4193530 & 4187369. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING CRACKED SYRINGES. MEDLINE COMPLAINT #: (B)(4). DEFECT DESCRIPTION: CRACKED SYRINGES (QUANTITY (B)(4)). MEDLINE PART #: 153239. PRODUCT DESCRIPTION: DNQSYRINGE 10ML LL BNS. VENDOR PART #: 304657. LOT #: 4193530 & 4187369. DATE REPORTED: 11/6/2024. SAMPLE RECEIVED: YES. RESPONSE NEEDED: SUMMARY OF FINDINGS AND CORRECTIVE ACTION.

    Description of Event or Problem · 0

    ADDITIONAL EVENT DETAILS IN H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437466 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4187369 00382903046577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown