BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 18074400 · Received November 6, 2023

    Report

    Report Number
    9610847-2023-00293
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 17, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K110771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBERS 3212582, 3179209, 3118884, 3212582, 3088057, 3150615, AND 3150613. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    (B)(4) 1: INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT. DEVICE PROBLEM CODE: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. LOT MANUFACTURE DATES: 3212582 - 2023-08-08 . 3179209 - 2023-07-27. 3118884 - 2023-05-18 . 3212582 - 2023-08-08 . 3088057 - 2023-05-02 . 3150615 - 2023-06-12 . 3150613 - 2023-06-05.

    Description of Event or Problem · 0

    MAT#:(B)(4) BATCH#:3212582, 3179209, 3118884, 3212582, 3088057, 3150615, 3150613 IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE NOTICED THAT THERE ARE A LOT OF PARTICLES IN THE FINAL PRODUCT WHEN USING THE 20 CC SYRINGE TRAYS (ITEM # 305617). THEY HAVE ALREADY RULED OUT THAT IT IS NOT FROM THE DRUG. IT HAS BEEN SEEN IN EVERY LOT THEY CURRENTLY HAVE IN STOCK (3212582, 3179209, 3118884, 3212582, 3088057, 3150615, 3150613). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE NOTICED THAT THERE ARE A LOT OF PARTICLES IN THE FINAL PRODUCT WHEN USING THE 20 CC SYRINGE TRAYS (ITEM # 305617). WE HAVE ALREADY RULED OUT THAT IT IS NOT FROM THE DRUG. IT HAS BEEN SEEN IN EVERY LOT WE CURRENTLY HAVE IN STOCK (3212582, 3179209, 3118884, 3212582, 3088057, 3150615, 3150613). CAN YOU PLEASE LOOK INTO THIS FOR US AS WE HAD TO DISCARD ALOT OF THE FINAL PRODUCTS AS WE CAN¿T SELL THEM WITH THIS ISSUE. 19 OCT 23 HELLO, THANK YOU FOR GETTING BACK TO US. HERE IS THE INFORMATION THAT YOU ASKED FOR. COULD YOU PLEASE PROVIDE OCCURRENCE DATE FOR THE INCIDENT?- WE HAVE SEEN THIS OCCURRING STARTING IN SEPTEMBER UNTIL RECENTLY. HOW MANY QUANTITIES AFFECTED IN THIS INCIDENT? IT WILL BE HELPFUL IF YOU CAN PROVIDE THE QUANTITIES FOR EACH LOT THAT HAS BEEN AFFECTED. 3212582, 3212582, 3088057, 3150615, 3150613- WE HAVE NO DATA ON THESE LOTS 3179209 (1045), 3118884 (1525), 3150617 (1579) COULD YOU PLEASE PROVIDE THE LOCATION WHERE THE PARTICLES HAVE BEEN FOUND?- THE PARTICLES WERE SEEN WHILE WE WERE VISUALIZING THE FINAL PRODUCT. WE SWIRL AND INVERT THE SYRINGE AND THE PARTICLE WOULD EITHER FALL DOWN OR RISE UP. IS THERE A PHOTO OR SAMPLE AVAILABLE FOR OUR REVIEW? IF SAMPLE IS AVAILABLE, PLEASE SEND ONLY 3-5 AFFECTED SAMPLES AND CONFIRM YOUR ADDRESS FOR RETURN LABEL. I WILL LOOK INTO THIS AND GET BACK TO YOU ABOUT THE SAMPLES.

    Description of Event or Problem · 0

    MAT#:305617. BATCH#:3212582, 3179209, 3118884, 3212582, 3088057, 3150615, 3150613. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE NOTICED THAT THERE ARE A LOT OF PARTICLES IN THE FINAL PRODUCT WHEN USING THE 20 CC SYRINGE TRAYS (ITEM # 305617). THEY HAVE ALREADY RULED OUT THAT IT IS NOT FROM THE DRUG. IT HAS BEEN SEEN IN EVERY LOT THEY CURRENTLY HAVE IN STOCK (3212582, 3179209, 3118884, 3212582, 3088057, 3150615, 3150613). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE NOTICED THAT THERE ARE A LOT OF PARTICLES IN THE FINAL PRODUCT WHEN USING THE 20 CC SYRINGE TRAYS (ITEM # 305617). WE HAVE ALREADY RULED OUT THAT IT IS NOT FROM THE DRUG. IT HAS BEEN SEEN IN EVERY LOT WE CURRENTLY HAVE IN STOCK (3212582, 3179209, 3118884, 3212582, 3088057, 3150615, 3150613). CAN YOU PLEASE LOOK INTO THIS FOR US AS WE HAD TO DISCARD ALOT OF THE FINAL PRODUCTS AS WE CAN¿T SELL THEM WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917138 SYRINGE 20ML LL TIP CONV PAK SYRINGE, PISTON FMF BECTON DICKINSON 3150613 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown