BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANSPACH

    MDR report key: 1523111 · Received November 4, 2009

    Report

    Report Number
    2522801-2009-00034
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 4, 2009
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CLASS 1 DEVICE - 510(K) EXEMPT. THE COMPONENTS FOR THIS ITEM ARE PROVIDED BY ANSPACH. ANGIOTECH, READING ASSEMBLES THE FINISHED GOOD ITEM, HAND PACKS, HAND SEALS, STERILIZES AND RETURNS TO ANSPACH FOR DISTRIBUTION. METHOD: THE ACTUAL PIECE WAS RETURNED AND VISUALLY EXAMINED. RESULTS/CONCLUSION: THE SEAL ON THE INNER TYVEK PACKAGE WAS OMITTED DURING THE PACKAGING/SEALING OPERATION. THIS IS A PACKAGING ISSUE, NOT A PRODUCT DEFECT. ELEVEN THOUSAND SEVEN HUNDRED AND TWENTY EIGHT (11, 728) PIECES WERE ASSEMBLED, PACKAGED, SEALED AND STERILIZED FOR THIS SPECIFIC LOT AND RETURNED TO ANSPACH. ONE (1) PACKAGE WAS FOUND DEFECTIVE. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE ITEM/LOT REPORTED. NO PERTINENT FINDINGS WERE NOTED. CORRECTIVE ACTION: AWARENESS TRAINING WAS PERFORMED FOR THE PACKAGING EMPLOYEES AND DOCUMENTED BY THE PACKAGING SUPERVISOR. (B)(4). ITEM # 64-0032-1, ANSPACH, IRRIGATION TUBING AND CLIPS, LOT# M607900.

    Description of Event or Problem · 1

    THE QUALITY ANALYST FROM ANSPACH REPORTED THAT DURING A ROUTINE INSPECTION, THE SEAL ON THE INNER TYVEK POUCH WAS MISSING ON THE PACKAGE CONTAINING THE IRRIGATION TUBING AND CLIPS ASSEMBLY. THE PRODUCT IS SOLD AS A STERILE DEVICE. THE STERILITY WAS COMPROMISED WHICH MAY CAUSE INJURY WHEN USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANSPACH IRRIGATION TUBING & CLIPS HRX THE ANSPACH EFFORT, INC. 64-0032-1 M607900

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE MADE AVAILABLE.