BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 23X1 RB

    MDR report key: 10411647 · Received August 14, 2020

    Report

    Report Number
    1213809-2020-00533
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 24, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.2. EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. B.6. RELEVANT TESTS/LABORATORY DATA: CONSUMER WENT TO THE HOSPITAL AND RECEIVED XRAYS. F.10. DEVICE CODES: 2993. H.1. TYPE OF REPORTABLE EVENTS: SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. BASED ON THE VERBATIM, IT APPEARS THE DEVICE FUNCTIONED AS EXPECTED. THE REPORTED DEFECT WAS UNFORTUNATELY NOT IDENTIFIED. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB RETRACTED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305271, BATCH NO: 8092761. IT WAS REPORTED THAT THE CONSUMER FOUND WHEN INJECTING THAT THE NEEDLE RETRACTED. VERBATIM: CONSUMER REPORTED FOUND WHEN INJECTING, THE NEEDLE RETRACTED. NOTED THIS WAS THE FIRST TIME RETRACTING WHEN INJECTING. THOUGHT THE NEEDLE BROKE IN HIS SITE. WENT TO THE HOSPITAL. THEY COMPLETED XRAYS AND INFORMED HIM TO CALL BD. THEY DID NOT PROVIDE RESULTS OF X RAY. WHEN I SPOKE WITH HIM I INFORMED IT WAS A RETRACTING NEEDLE AND HOW THE PRODUCT WORKED. HE REMOVED THE NEEDLE HUB AND FOUND THE NEEDLE AND SPRING. WAS HAPPY TO FIND THE NEEDLE AND SATISFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB RETRACTED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(6) BATCH NO: 8092761 IT WAS REPORTED THAT THE CONSUMER FOUND WHEN INJECTING THAT THE NEEDLE RETRACTED. VERBATIM: CONSUMER REPORTED FOUND WHEN INJECTING, THE NEEDLE RETRACTED. NOTED THIS WAS THE FIRST TIME RETRACTING WHEN INJECTING. THOUGHT THE NEEDLE BROKE IN HIS SITE. WENT TO THE HOSPITAL. THEY COMPLETED XRAYS AND INFORMED HIM TO CALL BD. THEY DID NOT PROVIDE RESULTS OF X RAY. WHEN I SPOKE WITH HIM I INFORMED IT WAS A RETRACTING NEEDLE AND HOW THE PRODUCT WORKED. HE REMOVED THE NEEDLE HUB AND FOUND THE NEEDLE AND SPRING. WAS HAPPY TO FIND THE NEEDLE AND SATISFIED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE INTEGRA 3 ML W/ NDL 23 X 1 RB RETRACTED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305271, BATCH NO: 8092761. IT WAS REPORTED THAT THE CONSUMER FOUND WHEN INJECTING THAT THE NEEDLE RETRACTED. VERBATIM: CONSUMER REPORTED FOUND WHEN INJECTING, THE NEEDLE RETRACTED. NOTED THIS WAS THE FIRST TIME RETRACTING WHEN INJECTING. THOUGHT THE NEEDLE BROKE IN HIS SITE. WENT TO THE HOSPITAL. THEY COMPLETED XRAYS AND INFORMED HIM TO CALL BD. THEY DID NOT PROVIDE RESULTS OF X RAY. WHEN I SPOKE WITH HIM I INFORMED IT WAS A RETRACTING NEEDLE AND HOW THE PRODUCT WORKED. HE REMOVED THE NEEDLE HUB AND FOUND THE NEEDLE AND SPRING. WAS HAPPY TO FIND THE NEEDLE AND SATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870250 SYRINGE INTEGRA 3ML W/NDL 23X1 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305271 8092761 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R