BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE CONTROL 10ML LL

    MDR report key: 20320842 · Received September 27, 2024

    Report

    Report Number
    1213809-2024-00670
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 4179466 AND OTHER EXPIRATION DATE INCLUDES 2029-05-31. 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 2024-06-27.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: ELEVEN SAMPLES FROM BATCH 4179466 AND TWO SAMPLES FROM BATCH 4164479 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NINE SAMPLES FROM BATCH 4179466 OBSERVED TO HAVE AN OPEN SIDE SEAL WITH GRID RANGING FROM 2" TO 4", AND BOTH PACKAGES FROM BATCH 4164479 HAVING THE SIDE SEAL OPEN WITH GRID GREATER THAN 2". THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE OPEN SEAL WITH GRID DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. QUALITY ALERT WILL BE ISSUED TO THE PLANT, AND RE-TRAINING WILL BE PROVIDED TO RESPONSIBLE ASSOCIATE TO ADDRESS THESE ISSUES. ADDITIONALLY, COMMUNICATION TO ALL TECHNICAL RESOURCES TO DOCUMENT ADJUSTMENTS ON THE PRODUCTION RECORDS FOLLOWING REPAIRS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4179466 AND 4164479. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL # 309695, BATCH # 4179466, 4164479. IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL PACKAGE SEAL INTEGRITY WAS POOR / QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED THE SEAL AROUND THE EDGE OF THE STERILE PACKAGING IS FAILING, CAUSING STERILITY ISSUES IN PROCEDURE ROOMS/OPERATING ROOMS. EVENT DATE: 9-11-2024, PRODUCT NAME: ITM-1150085 - SYRINGE 10ML CONTROL, PRODUCT REF: (B)(4), LOT NUMBERS: 4179466 AND 4164479, BD CUSTOMER ACCOUNT NUMBER: (B)(6), LOT 4179466: (B)(4) EACHES, LOT 4164479: (B)(4) EACHES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433750 BD SYRINGE CONTROL 10ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4164479 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown