BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE CONTROL 10ML LL BNS

    MDR report key: 8965794 · Received September 5, 2019

    Report

    Report Number
    1213809-2019-00894
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT SUBMISSION HAS BEEN IDENTIFIED AS A DUPLICATE OF MFR REPORT # 1213809-2019-00896. THIS COMPLAINT/MDR SHOULD THEREFORE BE DISREGARDED. ANY ADDITIONAL INFORMATION RELATED TO THIS COMPLAINT WILL BE ADDED TO MFR REPORT # 1213809-2019-00896.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SYRINGE CONTROL 10ML LL BNS EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 304134 BATCH NO. 9023770. EVENT DATE: UNKNOWN. PRODUCT MALFUNCTION/FAILURE MODE: BROKE. PRODUCT DESCRIPTION SUMMARY: THE CONTROL RINGS OF THE CONTROL SYRINGE BROKE OFF DURING INJECTING. "THIS HAS NOW HAPPENED FOUR TIMES." "THE DOCTOR GOT INJURED WHEN THE RINGS BROKE." COMPLAINT QUANTITY: 4. COMPONENT NAME: SYR,CONTROL, 10CC, L/L, W/O SHLD, NS ST=309695LF. WAS THERE AN INJURY: YES. WAS THERE A DEATH: NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 SYRINGE CONTROL 10ML LL BNS EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 304134, BATCH NO. 9023770. EVENT DATE: UNKNOWN. PRODUCT MALFUNCTION/FAILURE MODE: BROKE. PRODUCT DESCRIPTION SUMMARY: THE CONTROL RINGS OF THE CONTROL SYRINGE BROKE OFF DURING INJECTING. "THIS HAS NOW HAPPENED FOUR TIMES." "THE DOCTOR GOT INJURED WHEN THE RINGS BROKE." COMPLAINT QUANTITY: 4. COMPONENT NAME: SYR,CONTROL,10CC,L/L,W/O SHLD,NS ST=309695LF. WAS THERE AN INJURY: YES. WAS THERE A DEATH: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759583 SYRINGE CONTROL 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9023770

    Patients

    Seq Age Sex Outcome Treatment
    1 Other