BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 12920162 · Received December 2, 2021

    Report

    Report Number
    1213809-2021-00788
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1168669. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-06-17. MEDICAL DEVICE LOT #: 1110057. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-04-20. MEDICAL DEVICE LOT #: 9093524. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-04-03. MEDICAL DEVICE LOT #: 0329605. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-11-24. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/23/2021. H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED SHOWING EACH SHOWING LOOSE 3ML INTEGRA SYRINGE WITH NEEDLE (P/N 305270). THE STOPPER WAS OBSERVED IN BOTH PHOTOS AND EXAMINED FOR ANY IRREGULAR ANGULARITY ISSUES. NEITHER OF THE STOPPERS IN THE PHOTOS APPEARED TO BE NON-CONFORMING PER PRODUCT SPECIFICATION. ADDITIONALLY, THREE HUNDRED SYRINGES WERE RECEIVED FOR EVALUATION. 100 EACH FROM BATCHES #1110057, 0329605, AND 1168669. NONE OF THE SYRINGES RECEIVED WERE OBSERVED TO HAVE ANY NON-CONFORMING STOPPER ANGULARITY ISSUES AND WERE ACCEPTABLE PER PRODUCT SPECIFICATION. SINCE THE SAMPLES RECEIVED DID NOT DISPLAY THE REPORTED CONDITION A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD INTEGRA¿ SYRINGES WITH DETACHABLE NEEDLE EACH FROM LOTS 1168669, 1110057, 9093524, AND 0329605 HAD DEFECTIVE/DEFORMED RUBBER STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER STATED THAT THE RUBBER STOPPER IS UNEVEN AND DIFFERENT THAN WHAT THEY HAVE HAD IN THE PAST."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD INTEGRA¿ SYRINGES WITH DETACHABLE NEEDLE EACH FROM LOTS 1168669, 1110057, 9093524, AND 0329605 HAD DEFECTIVE/DEFORMED RUBBER STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER STATED THAT THE RUBBER STOPPER IS UNEVEN AND DIFFERENT THAN WHAT THEY HAVE HAD IN THE PAST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819432 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305270 SEE SECTION H10 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown