BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 20653840 · Received November 11, 2024

    Report

    Report Number
    1213809-2024-00803
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - FOREIGN MATTER. TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BOTH PHOTOS SHOW ONE LOOSE SYRINGE WITH A DRAG MARK WITHIN THE SCALE MARKINGS AREA CAUSING ILLEGIBLE PRINT ON THE BARREL. NO FOREIGN MATTER DEFECTS WERE OBSERVED IN ANY OF THE PHOTOS RECEIVED. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SCALE MARKINGS DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY, SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4183027 AND 4227266. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 4183027 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 2024-07-01.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL#: 301027 BATCH#: 4173027, 4227266. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT COMPLAINTS/ CLAIMS NOT SURE WHO SHOULD HANDLE THIS ONE. HCT IS A DISTRIBUTOR AND NOTICED SOME UNCONFORMITIES ON THE SKU¿S BELOW. THEY WOULD LIKE TO RETURN. CUSTOMER CC¿D. 302995 ¿ 10ML 309646 ¿ 5ML REJECTED NON-STERILE SYRINGES. SYRINGES DID NOT PASS INSPECTION. CAN YOU PLEASE ADVISE HOW YOU WOULD LIKE US TO HANDLE THE REJECTED SYRINGES? SHOULD WE JUST EMAIL YOU WHAT CANNOT BE USED FOR A CREDIT? DO YOU NEED THEM RETURNED OR CAN WE DISPOSE OF THEM? HI (B)(6). WE HAVE IDENTIFIED A NONCONFORMITY IN 5 AND 10ML BD SYRINGES (LOTS: 4183027, 4227266, 4243178, 4180037). WE ARE INSPECTING APPROXIMATELY 200 SYRINGES FOR CONTAMINATION AND 29 SYRINGES FOR PRINTING. THANK YOU. ADDITIONAL INFORMATION PROVIDED: DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? NO 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO 3. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? CHECKING 4. BATCH NUMBER [4183027, 4227266] WAS NOT FOUND FOR MATERIAL NUMBER # 309646, KINDLY VERIFY THE SAME. CHECKING. 5. TOTAL NUMBER OF OCCURRENCES OF ONLY 5 ML SYRINGE? CHECKING 6. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SEE PICTURES ATTACHED. 7. INSPECTED 29 SYRINGES FOR PRINTING, CAN YOU PLEASE ELABORATE THIS ISSUE WHY THIS WAS INSPECTED? WHETHER ANY SCALE MARKING ISSUE ON THE SYRINGE. PLEASE SEE THE PICTURES ATTACHED. I AM GETTING ADDITIONAL DETAILS ON THIS. THE LOTS FOR THE 5ML SYRINGES IS 4183027 AND 4227266. THE EVENT DATE IS 10/10/2024 ARE WE ABLE TO GET CREDIT FOR THE 29 EACH? 1. TOTAL NUMBER OF OCCURRENCES OF ONLY 5 ML SYRINGE? CHECKING 2. INSPECTED 29 SYRINGES FOR PRINTING, CAN YOU PLEASE ELABORATE THIS ISSUE WHY THIS WAS INSPECTED? WHETHER ANY SCALE MARKING ISSUE ON THE SYRINGE. PLEASE SEE THE PICTURES ATTACHED. I AM GETTING ADDITIONAL DETAILS ON THIS. THESE ARE YOUR NON-STERILE SYRINGES. WE PURCHASE THESE AND PUT THEM INTO KITS BEFORE BEING STERILIZED. THEY ARE INSPECTED PRIOR TO BEING PLACED INSIDE OUR CUSTOM KITS. 30 SYRINGES HAD CONTAMINATION AND 23 HAD LABELING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568387 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4227266 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown