BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8102952 · Received November 26, 2018

    Report

    Report Number
    9610048-2018-00208
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    July 12, 2018
    Report Date
    November 21, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K984059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7265547. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2017-09-29. MEDICAL DEVICE LOT #: 8059684. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-02-28. " (B)(6). INVESTIGATION SUMMARY: OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE REPORTED COMPLAINT ON ONE OF THE RETUNED SAMPLES ONLY. RECEIVED TWO UNUSED SAMPLES IN OPEN EMBEDDING OF THE PRODUCT ANGIOCATH 22GX1.00IN, CATALOG: 388335. A SAMPLE FROM THE BATCH: (B)(4) WITHOUT THE PLUG AND A BATCH SAMPLES: (B)(4) WITH THE CATHETER ONLY. FOR THE LOT SAMPLE: 7265547 VISUAL ANALYSIS UNDER MAGNIFICATION WAS PERFORMED AND NO NEEDLE CLOGGING WAS OBSERVED. FOR THE BATCH SAMPLE: (B)(4) AFTER VISUAL ANALYSIS UNDER MAGNIFICATION IT CAN BE SEEN THAT THE CATHETER WAS CLOGGED. AFTER PASSAGE OF A METALLIC WIRE INTO THE CATHETER IT WAS POSSIBLE TO REMOVE A SOFT AND TRANSPARENT PARTICULATE FROM THE INSIDE OF THE WEDGE METAL THAT IS INSIDE THE ADAPTER AND HAS THE FUNCTION OF CRIMPING THE CATHETER WITHIN THE ADAPTER. THUS, IT IS BELIEVED, THAT THIS PARTICLE IS RESPONSIBLE FOR THE CAUSE OF THE CLOGGING. HOWEVER, IN INVESTIGATING THE ASSEMBLY PROCESS OF THIS PRODUCT, IT WAS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS DEFECT. FOR, IT CANNOT BE CONCLUDED AS THE CATHETER COULD HAVE BEEN CLOGGED, THE CANNULA HAD BEEN MOUNTED THEREIN WITHOUT TAKING THAT PARTICLE WITH IT AND THEN HAVING BEEN REMOVED FROM THE INNER OF THE CATHETER AND LEAVING THE PARTICLE INSIDE THE CATHETER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# (B)(4) LOT 7241709 MANUFACTURED FROM 30-AUG-17 TO 29-SEP-17 AT ACAM03 MACHINE USED IN CLAIMED LOT 7265547. THIS LOT HAS BEEN WAS ANALYZED FOR THE TESTS TO VERIFY THE CANNULA OCCLUSION AND NO RECORDS WERE DETECTED DURING THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# (B)(4) LOT 8025730 MANUFACTURED FROM 31-JAN-18 TO 28-FEB-18 IN ACAM03 MACHINE USED IN CLAIMED LOT 8059684. THIS LOT HAS BEEN WAS ANALYZED FOR THE TESTS TO VERIFY THE CANNULA OCCLUSION AND NO RECORDS WERE DETECTED DURING THIS ANALYSIS. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF THAT COULD LEAD TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGERS OF BD ANGIOCATH¿ IV CATHETERS WERE DIFFICULT TO MOVE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, SERIOUS INJURY, OR BLOOD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940408 BD ANGIOCATH¿ IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other