BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 ML BD LUER-LOK CONTROL SYRINGE

    MDR report key: 8967349 · Received September 5, 2019

    Report

    Report Number
    1213809-2019-00896
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 17, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. POTENTIAL ROOT CAUSE FOR THE BROKEN THUMB GRIP DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE DEFECT WAS FOUND IN PRODUCTION, A QUALITY NOTIFICATION WAS ISSUED, AND PRODUCT WAS REQUALIFIED PER APPLICABLE AQL. IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION ESCAPED DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ML BD LUER-LOK¿ CONTROL SYRINGE WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 304134 BATCH NO. 9023770 IT WAS REPORTED THE "CONTROL RINGS IN THE SYRINGE BROKE OFF DURING INJECTING." EVENT DATE: (B)(6) 2019 PRODUCT MALFUNCTION/FAILURE MODE: BROKE PRODUCT DESCRIPTION SUMMARY: CONTROL RINGS IN THE SYRINGE BROKE OFF DURING INJECTING. COMPLAINT QUANTITY: 1 SAMPLE AVAILABLE: NO WAS THERE AN INJURY: YES WAS THERE A DEATH: NO CUSTOMER STATED: THE INCIDENT OCCURRED WHILE INJECTING A PATIENT. DURING INJECTION THE HANDLE BROKE OFF CAUSING THE SURGEON TO LOSE CONTROL. THE SYRINGE SLIPPED AND HE WAS STABBED IN THE BACK OF THE NON-INJECTING HAND. THE MD WAS SCREENED AND THE RESULTS CAME BACK NEGATIVE. THERE WAS MINIMAL DELAY WHILE SURGEON ASSESSED AND CLEANED THE ACCIDENTAL POKE SITE. I¿M UNSURE OF THE SPECIFIC SURGERY, BUT COULD DO MORE RESEARCH IF NECESSARY. IT WAS A HAND OR WRIST PROCEDURE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 WAS REPORTED THAT 10 ML BD LUER-LOK¿ CONTROL SYRINGE WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 304134 BATCH NO. 9023770. IT WAS REPORTED THE "CONTROL RINGS IN THE SYRINGE BROKE OFF DURING INJECTING." EVENT DATE: (B)(6) 2019. PRODUCT MALFUNCTION/FAILURE MODE: BROKE. PRODUCT DESCRIPTION SUMMARY: CONTROL RINGS IN THE SYRINGE BROKE OFF DURING INJECTING. COMPLAINT QUANTITY: 1. SAMPLE AVAILABLE: NO. WAS THERE AN INJURY: YES. WAS THERE A DEATH: NO. CUSTOMER STATED: THE INCIDENT OCCURRED WHILE INJECTING A PATIENT. DURING INJECTION THE HANDLE BROKE OFF CAUSING THE SURGEON TO LOSE CONTROL. THE SYRINGE SLIPPED AND HE WAS STABBED IN THE BACK OF THE NON-INJECTING HAND. THE MD WAS SCREENED AND THE RESULTS CAME BACK NEGATIVE. THERE WAS MINIMAL DELAY WHILE SURGEON ASSESSED AND CLEANED THE ACCIDENTAL POKE SITE. I¿M UNSURE OF THE SPECIFIC SURGERY, BUT COULD DO MORE RESEARCH IF NECESSARY. IT WAS A HAND OR WRIST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761809 10 ML BD LUER-LOK CONTROL SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9023770

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other