BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION TUBE, 10 CM LENGTH, 15F/15M

    MDR report key: 56178 · Received December 9, 1996

    Report

    Report Number
    9681384-1996-00021
    Event Type
    Malfunction
    Date Received
    December 9, 1996
    Date of Event
    November 6, 1996
    Report Date
    December 6, 1996
    Manufacturer
    MALLINCKRODT MEDICAL, INC SPA
    Product Code
    CAH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6, CODE 86: DIMENSIONAL MEASUREMENTS TAKEN. H6, CODE 68: MATERIAL CHANGES HAVE BEEN MADE TO THIS PRODUCT SINCE THIS MFG LOT HAD BEEN PRODUCED. THE ANALYSIS OF THE RETURNED SAMPLE SHOWED THE ACTUAL PRESENCE OF THE COMPLAINED DEFECT. THE DIMENSIONAL CHECK WE MADE SHOWED THE FLAT PART OF THE TUBE WAS MFR WITH AN OLD TYPE OF MATERIAL. IN FACT, THE MODIFICATION APPLICATION 60/96 DATED MAY 22, 1996 STATED THE CHANGE OF THE ABOVE MENTIONED MATERIAL WITH A NEW ONE THAT TURNED OUT TO BE STRONGER (REF. TEST REPORT ATTACHED). SINCE THE APPLICATION OF THE MOD. APPL. 60/96 WE HAVE NOT RECEIVED ANY TYPE OF NEGATIVE FEEDBACK FROM CUSTOMERS CONCERNING THE CAHTETER MOUNT, FURTHERLY CONFIRMING THE POSITIVE IMPACT OF THE CHANGE WE DECIDED. THE FIRST BATCH PRODUCED FOLLOWING THE ABOVE IS DAR 331/5113, BATCH 6/12110 (Q.TY 20 PIECES).

    Description of Event or Problem · 1

    THE EXTENSION TUBE SPLIT ALONG ONE OF THE SPIRAL REINFORCEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION TUBE, 10 CM LENGTH, 15F/15M EXTENSION TUBE CAH MALLINCKRODT MEDICAL, INC SPA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening