BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 9534139 · Received December 31, 2019

    Report

    Report Number
    1213809-2019-01316
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    November 29, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. THE LOT NUMBER 1257026 IS EXPIRED, THE MANUFACTURING PLANT IS UNABLE TO VERIFY. THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. FOR LOT NUMBER 8318741,8297832, DURING THE DOCUMENTARY REVIEW, NO QUALITY NOTIFICATIONS WERE FOUND THAT COULD CAUSE THE DEFECT REPORTED BY THE CLIENT, THE LOT WAS INSPECTED AND APPROVED IN ACCORDANCE WITH THE ESTABLISHED QUALITY GUIDELINES. CAPA#1132752 IS CURRENTLY UNDER INVESTIGATION, WITH WHICH IT IS SOUGHT TO IDENTIFY POSSIBLE FAILURE MODES THAT CAUSE THE DEFECT, AS WELL AS POSSIBLE IMPROVEMENTS, LIKEWISE, IT SHOULD BE NOTED THAT THE LOT WAS MANUFACTURED PRIOR TO THE CLOSURE OF THE CAPA. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL 200 S/C HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657, BATCH NO.: UNKNOWN. POSSIBLE LOTS: 9225551, 1257026, 8318741, 8297832, 9186751 THE CUSTOMER PULLED 5 BD 3ML SYRINGES FROM THEIR SUPPLY ROOM AS ONLY ONE WAS SAVED AND THEY WANTED TO BD TO HAVE A MIX OF LOT NUMBERS TO TEST. IT WAS REPORTED THE 3ML SYRINGES APPEAR TO LEAK WHEN CONNECTED TO A BD MAXZERO NEEDLELESS CONNECTOR. VERBATIM: I MET WITH THE NICU MANAGER TODAY REGARDING THE CONTINUED INCIDENTS THEIR NICU HAS BEEN HAVING WITH WHAT APPEARS TO BE LEAKING FROM BD 3ML SYRINGES WHEN CONNECTED TO A BD MAXZERO NEEDLELESS CONNECTOR. PLEASE NOTE THAT NICU MANAGER BELIEVES THAT THE LEAKING HAS BEEN HAPPENING MORE FREQUENTLY THAN THE REPORTED EVENTS BASED ON HER RECENT CONVERSATIONS WITH HER NURSES. PLEASE ALSO NOTE THAT THIS MAY ALSO BE HAPPENING WITH BD 1ML SYRINGES, WASN'T 100% SURE. COMPLAINT 3 OF 4.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9225551. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-08-22. MEDICAL DEVICE LOT #: 1257026. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 8318741. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2018-12-12. MEDICAL DEVICE LOT #: 8297832. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-11-19. MEDICAL DEVICE LOT #: 9186751. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-07-17. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL 200 S/C HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: UNKNOWN. POSSIBLE LOTS: 9225551, 1257026, 8318741, 8297832, 9186751. **THE CUSTOMER PULLED 5 BD 3ML SYRINGES FROM THEIR SUPPLY ROOM AS ONLY ONE WAS SAVED AND THEY WANTED TO BD TO HAVE A MIX OF LOT NUMBERS TO TEST. IT WAS REPORTED THE 3ML SYRINGES APPEAR TO LEAK WHEN CONNECTED TO A BD MAXZERO NEEDLELESS CONNECTOR. VERBATIM: I MET WITH THE NICU MANAGER TODAY REGARDING THE CONTINUED INCIDENTS THEIR NICU HAS BEEN HAVING WITH WHAT APPEARS TO BE LEAKING FROM BD 3ML SYRINGES WHEN CONNECTED TO A BD MAXZERO NEEDLELESS CONNECTOR. *PLEASE NOTE THAT NICU MANAGER BELIEVES THAT THE LEAKING HAS BEEN HAPPENING MORE FREQUENTLY THAN THE REPORTED EVENTS BASED ON HER RECENT CONVERSATIONS WITH HER NURSES. **PLEASE ALSO NOTE THAT THIS MAY ALSO BE HAPPENING WITH BD 1ML SYRINGES, WASN'T 100% SURE. COMPLAINT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331567 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H.10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other