BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 10557404 · Received September 18, 2020

    Report

    Report Number
    1911916-2020-00876
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 21, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 0042292. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML REG PR SALINE 10ML FILL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SYRINGE LEAKED OUT OF THE PLUNGER. EVENT DESCRIPTION: HERE IS AN ADDITIONAL PRODUCT ISSUE FOR THE PREFILLED SALINE SYRINGE, DETAILS ARE BELOW PRODUCT MANUFACTURE NUMBER- 8290306546, LOT NUMBER 0042292 ISSUE IDENTIFIED- SYRINGE LEAKED OUT THE BACK OF THE PLUNGER WHILE INFUSING INTO PATIENT'S CATHETER. DATE REPORTED 8/27. XXX XXX HAS THE SYRINGE IN HER OFFICE. PLEASE SEND A RETURN PACKAGE FOR THIS TO BE RETURNED FOR ANALYSIS.

    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 10ML REG PR SALINE 10ML FILL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SYRINGE LEAKED OUT OF THE PLUNGER. EVENT DESCRIPTION: HERE IS AN ADDITIONAL PRODUCT ISSUE FOR THE PREFILLED SALINE SYRINGE, DETAILS ARE BELOW PRODUCT MANUFACTURE NUMBER- 8290306546, LOT NUMBER 0042292 ISSUE IDENTIFIED- SYRINGE LEAKED OUT THE BACK OF THE PLUNGER WHILE INFUSING INTO PATIENT'S CATHETER. DATE REPORTED 8/27. XXX XXX HAS THE SYRINGE IN HER OFFICE. PLEASE SEND A RETURN PACKAGE FOR THIS TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022018 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0042292 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other