BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7200503 · Received January 17, 2018

    Report

    Report Number
    9610048-2017-00117
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    November 28, 2017
    Report Date
    February 20, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811237
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENTS IN QUESTION. VISIBLE SILICONE: THROUGH ANALYSIS OF THE SAMPLES PERFORMED BY THE USA AND FTIR RESULTS, IT IS POSSIBLE TO CONFIRM THE PRESENCE OF SILICONE ON THE CATHETER. IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE DAMAGE TO THE WEARER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. FOREIGN MATTER: AFTER ANALYSIS AND THE FTIR RESULTS, IT WAS POSSIBLE TO VERIFY THE PRESENCE OF PARTICLES ON THE CATHETER. SAMPLES: THE PRESENCE OF SILICONE DROPLETS AND FOREIGN MATTER ON THE CATHETER WAS CONFIRMED. DHR/ QN/ NCMR REVIEW: AFTER ANALYSIS OF THE RECLAIMED LOTS OF ASSEMBLED SET: 6361823, 6334521 AND 6292115 USED IN THE FINAL PRODUCT BATCHES: 7010867, 6362742 AND 6335845 OF ANGIOCATH 22GA X 1.00IN, NO EXCESS OF SILICONE WAS EVIDENCED IN THE TESTS PERFORMED DURING THE PRODUCTION OF THE BATCHES IN QUESTION AND AS TO THE TESTS TO VERIFY THE PRESENCE OF "FOREIGN / NO FOREIGN MATTER" AND NO RECORDS OF THIS DEFECT WERE EVIDENCED. QN/ NCMR REVIEW: THERE ARE NO RECORDS OF QUALITY NOTIFICATION (QN) OR NON-CONFORMANCE REPORT (RNC) OF FOREIGN MATTER, FOR THE LOT INVOLVED IN THIS CLAIM, ACCORDING TO THE HISTORY OF THE LOT ABOVE. FTIR RESULTS: THE FIRST FM SAMPLE I WAS UNABLE TO RETRIEVE THE FM AS IT WAS INSIDE THE CATHETER AND I COULDN¿T GET IT OUT. THE SECOND BLACK FM WAS ON THE SURFACE. IT IS LIKELY FROM A PIECE OF CLOTHING AS THE MATERIAL IS A MIX OF POLYESTER AND NYLON PLUS SILICONE. INVESTIGATION CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION ACCORDING TO STUDIES AND PLANS TO REDUCE FOREIGN MATTER COMPLAINTS PERFORMED IN JUIZ DE FORA PLANT, IT CAN BE DETERMINED AFTER ANALYZING THE SAMPLES AND FTIR RESULTS (WHICH SHOWS POLYESTER AND NYLON WITH SILICONE) THAT THE MOST PROBABLE SOURCE FOR THIS TYPE OF FOREIGN MATTER MAY BE PRESENT DUE TO THE FOLLOWING SITUATION. WHEN THE CATHETER IS POINTED, THEY GET EXPOSED ON SHELVES THAT HAD NOT ALL THE PROTECTIONS, AND BECAUSE THEY ARE IN A PLACE OF PEOPLE PASS, IT WAS LIKELY THAT SOME AIRBORNE PARTICLES WOULD REACH THE CATHETER THAT HAS SILICONE ALONG ITS SURFACE, AS EVIDENCED DURING INTERNAL INVESTIGATIONS. CAPA (B)(4) WAS OPENED TO INVESTIGATE FURTHER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7010871, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2017-01-23. MEDICAL DEVICE LOT #: 6362742, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2017-01-18. MEDICAL DEVICE LOT #: 6335845, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2016-12-16.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER THERE WAS FOREIGN MATTER ON THE CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42588 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10. 30382903811237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other