BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24 G X 0.75 IN. BD ANGIOCATH¿

    MDR report key: 6902865 · Received September 28, 2017

    Report

    Report Number
    9610048-2017-00041
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 7, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    NCP
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES/ PHOTOS: ACCORDING TO VISUAL ANALYSIS OF THE PHOTOS BY BD (B)(6) CONTAINING THE CLAIMED SAMPLES AND BASED ON THE ANALYSIS OF THE SAMPLES BY BD (B)(6), NO DAMAGE OR ABNORMALITY WAS IDENTIFIED IN THE SAMPLES RETURNED FROM THE CLIENT. DHR REVIEW: THE TIPPER CATHETER LOT: 6179393 MANUFACTURED FROM 01 TO 28 JUL, 2016 & 6152234SH FROM 16 TO 30 JUN, 2016, USED IN THE FINAL PRODUCT LOT: 6180339 OF ANGIOCATH 24GX0.75WW WERE ANALYZED AND RECORDS OF "DAMAGING ADAPTER" WERE EVIDENCED, WHICH COULD LEAD TO DAMAGE ON THE ADAPTER WHICH COULD LEAD TO DAMAGE AT LUER CONFECTION. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-COMPLIANCE REPORTING RECORDS OF LEAKAGE AND DAMAGED COMPONENT FOR THE LOTS INVOLVED IN THIS COMPLAINT, ACCORDING TO THE HISTORY OF THE LOT ABOVE. SAMPLES/ PHOTOS: THE CONCLUSION OF THE INVESTIGATIONS OF THIS COMPLAINT DOES NOT REQUIRE THE PRESENCE OF PHYSICAL SAMPLES, THE PHOTOS THAT ARE ATTACHED ARE SUFFICIENT FOR THE DETERMINATION OF THE DEFECT, NOT ALTERING THE INVESTIGATION PREVIOUSLY CARRIED OUT. IN ADDITION, AS THE SAMPLES WERE NOT RECEIVED UNTIL THE PRESENT MOMENT WHICH IS IMPACTING THE RESPONSE TIME OF THE CUSTOMER COMPLAINT. CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER COMPLAINT. INVESTIGATION COMMENTS: ALTHOUGH THE PHOTOS OF THE SAMPLE RETURNED FROM THE CLIENT DID NOT SHOW ANY DAMAGE TO THE ADAPTER ACCORDING TO THE ANALYSIS OF BD (B)(6), AND ALTHOUGH THE SAMPLE WAS ANALYZED BY BD (B)(6) AND SHOWED NO DAMAGE TO THE ADAPTER, THE COMPLAINT CAN BE CONFIRMED, SINCE THEY WERE EVIDENCED "ADAPTER DAMAGE" RECORDS IN THE BATCHES HISTORY INVOLVED IN THIS COMPLAINT THAT COULD LEAD TO LEAKAGE ON THE ADAPTER'S LUER CONNECTION, THUS CONFIRMING THIS COMPLAINT. ROOT CAUSE: VARIATIONS IN THE ALIGNMENT OF THE METAL TIPS IN THE MACHINES THAT PERFORM THE CATHETER TIPPING THAT MAY CAUSE THE DAMAGE VERIFIED IN THE ADAPTER WHICH MAY CAUSE THE INCIDENTS REPORTED IN THIS COMPLAINT. ADDITIONALLY, SAMPLES HAVE BEEN SENT TO THE MANUFACTURING SITE IN (B)(4) FOR A, (B)(6). UPON COMPLETION OF THE SECONDARY INVESTIGATION, AN ADDITIONAL SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SAMPLES/ PHOTOS: WERE RECEIVED TWO SAMPLES OF THE ANGIOCATH PRODUCT 24GX0.75 FOR ANALYSIS. AFTER VISUAL ANALYSIS UNDER MAGNIFICATION OF BOTH PRODUCTS, THERE WAS NO EVIDENCE OF DAMAGE TO THE ADAPTER LUER CONNECTION OR TO THE JUNCTION BETWEEN THE CATHETER AND THE ADAPTER. BOTH PIECES WERE SUBJECTED TO LEAKAGE TESTS AND ONE OF THEM PRESENTED A SMALL LEAKAGE IN THE JUNCTION BETWEEN ADAPTER AND CATHETER, HOWEVER, NO DAMAGE OR ABNORMALITY WERE IDENTIFIED IN ANY OF THE TWO SAMPLES RETURNED FROM THE CLIENT. IN ADDITION, IT WAS NOT POSSIBLE TO DISASSEMBLE THE CATHETER FROM THE ADAPTER FOR ANALYSIS, SINCE THE CATHETER IS FIRMLY ATTACHED TO THE ADAPTER AND COULD NOT BE REMOVED. ACCORDING TO VISUAL ANALYSIS OF THE PHOTOS BY BD JUIZ DE FORA CONTAINING THE CLAIMED SAMPLES AND BASED ON THE ANALYSIS OF THE SAMPLES BY BD JAPAN, NO DAMAGE OR ABNORMALITY WAS IDENTIFIED IN THE SAMPLES RETURNED FROM THE CLIENT. DHR REVIEW: THE TIPPER CATHETER LOT: 6179393 MANUFACTURED FROM 01 TO 28 JUL, 2016 & 6152234SH FROM 16 TO 30 JUN, 2016, USED IN THE FINAL PRODUCT LOT: 6180339 OF ANGIOCATH 24GX0.75WW WERE ANALYZED AND RECORDS OF "DAMAGING ADAPTER" WERE EVIDENCED, WHICH COULD LEAD TO DAMAGE ON THE ADAPTER WHICH COULD LEAD TO DAMAGE AT LUER CONECTION. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-COMPLIANCE REPORTING RECORDS OF LEAKAGE AND DAMAGED COMPONENT FOR THE LOTS INVOLVED IN THIS COMPLAINT, ACCORDING TO THE HISTORY OF THE LOT ABOVE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATIONS OF THE RETURNED SAMPLES IT WAS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE LEAKAGE IN THE ADAPTER CATHETER JUNCTION. HOWEVER, THE CONCLUSION OF THE INVESTIGATIONS OF THIS COMPLAINT DOES NOT REQUIRE THE PRESENCE OF PHYSICAL SAMPLES, AND THE EVALUATED PHOTOS ARE SUFFICIENT FOR THE DETERMINATION OF THE DEFECT. VARIATIONS IN THE ALIGNMENT OF THE METAL TIPS IN THE MACHINES THAT PERFORM THE CATHETER TIPPING THAT MAY CAUSE THE DAMAGE VERIFIED IN THE ADAPTER WHICH MAY CAUSE THE INCIDENTS REPORTED IN THIS COMPLAINT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 24 G X 0.75 IN. BD ANGIOCATH¿ LEAKED MEDICATION, DURING USE. NO REPORT OF MEDICAL INTERVENTION OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682489 24 G X 0.75 IN. BD ANGIOCATH¿ ARTERIAL CANNULA NCP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6180339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other