BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING ASPIRATING NEEDLE

    MDR report key: 2971329 · Received September 29, 2006

    Report

    Report Number
    1044475-2006-00020
    Event Type
    Malfunction
    Date Received
    September 29, 2006
    Date of Event
    June 18, 2006
    Report Date
    September 12, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY ALLEGES THAT THE DISTAL NEEDLE TIP FOR THE MEDIASTINOSCOPY SCOPE BROKE OFF INSIDE THE PATIENT. THEY REPORT THAT THE TIP WAS RETRIEVED BY THE PHYSICIAN AND THAT NO PATIENT INJURY OCCURRED. ON (B)(6), ONE CATALOG NUMBER 507454 (PILLING ASPIRATING NEEDLE) WAS RECEIVED FOR EVALUATION. DURING PRODUCT EVALUATION IT WAS DETERMINED THAT NO MANUFACTURING DEFECTS WERE EVIDENT. EVALUATION REVEALED THAT THE TIP OF THE ASPIRATING NEEDLE WAS SOLDERED INTO THE HOLE. EVALUATION ALSO REVEALED THAT THE TIP OF THE NEEDLE WAS BENT AT THE JUNCTION OF THE HUB, WHICH RESULTED IN FRACTURING THE SOLDER JOINT. TELEFLEX MEDICAL WAS NOT ABLE TO DETERMINE WHEN THE DEVICE WAS ORIGINALLY BENT. TRENDING OF CATALOG NUMBER 507454 (PILLING ASPIRATING NEEDLE) FOR THE PAST TWELVE MONTHS REVEALS THAT THERE HAS NOT BEEN ANY SIMILAR COMPLAINTS ON THIS PRODUCT.

    Description of Event or Problem · 1

    ASPIRATING NEEDLE TIP BROKE OFF DURING A MEDIASTINOSCOPY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING ASPIRATING NEEDLE ASPIRATING NEEDLE GAA TELEFLEX MEDICAL NA QQ5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention