BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES

    MDR report key: 7088115 · Received December 6, 2017

    Report

    Report Number
    9610048-2017-00076
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 29, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903811373
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW WAS PERFORMED. THE CLAIMED BATCH 5173431 OF ANGIOCATH 20GX1.88WW WAS ANALYZED FOR THE TESTS THAT COULD LEAD TO CLAIMED DEFECT, SUCH AS: ADHESIVE TRANSFER TEST, WHICH IS EVIDENCE THROUGH MARK OF THE SEALING FILM, THE ADHESIVENESS OF THE PAPER WAS TRANSFERRED TO THE BOTTOM WEB, ASSURING THE SEALING OF THE PRODUCT; PACKAGING LEAKAGE TEST, WHICH IS A TEST THAT CHALLENGES THE INTEGRITY OF THE SEALING, AS THE HOLES, SEALING CHANNELS OR ANY OTHER BREACH OF THE SEALING THAT COULD COMPROMISE THE STERILIZATION OF THE PRODUCT; WIDTH AND SEALING TEST, WHICH EVALUATES THE PARAMETER ACCORDING INTERNALLY SPECIFIED THAT THE WIDTH OF THE SEAL SHOULD BE GREATER THAN 3.2 MM ALSO WERE ALL WITHIN SPECIFICATIONS. ALL PARAMETERS OF THE SEALING MACHINE WERE WITHIN THAT SPECIFIED FOR THE CLAIMED LOT. BASED ON THIS ANALYSIS, NO RECORDS WERE FOUND THAT COULD LEAD TO THE INCIDENT IN QUESTION. CONCLUSION: OUR QUALITY ENGINEER WAS UNABLE TO VERIFY THE REPORTED COMPLAINT. THERE WERE NO RECORDS OF FAILURE/INTEGRITY OF THE SEALING IN THE BATCH HISTORY ANALYZES AND IN THE RECORDS OF NO-CONFORMITY OR QUALITY NOTIFICATION FOR THE CLAIMED LOT. IN ADDITION, ALTHOUGH THE SAMPLE PACKS WERE REPORTED TO BE OPEN PRIOR TO PRODUCT USE, SAMPLES OR PHOTOS OF THE PRODUCT ARE NOT AVAILABLE FOR ANALYSIS. WITHOUT A SAMPLE, IT HAS NOT BEEN POSSIBLE TO REACH A CONCLUSION ON THE ROOT CAUSE OF THE DEFECT IN QUESTION. IT WAS DETERMINED TO IMPLEMENT ACTION CHANGE CONTROL 084/15 WHICH CONTEMPLATES THE EXCHANGE OF THE SUPPLIER OF THE PAPER FROM OLIVER TOLAS TO ARJO WHICH DOES NOT HAVE LACQUER AS ADHESIVE, SINCE THE ADHESIVENESS OF THE PAPER WILL BE CARRIED OUT IN ANOTHER WAY. THIS ACTION WAS COMPLETED ON 11/20/2017. IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES THE NURSE FOUND UNIT PACKAGE SEAL OPEN BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865829 BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES INTRAVENOUS CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5173431 00382903811373

    Patients

    Seq Age Sex Outcome Treatment
    1 Other