BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER 22G X 1.16 IN

    MDR report key: 6991896 · Received October 31, 2017

    Report

    Report Number
    9610048-2017-00055
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 7, 2017
    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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SAMPLES/PHOTOS: WERE RECEIVED TWO OPENED AND UNUSED SAMPLES RETURNED FROM CUSTOMER OF BATCH: 6084422 FROM ANGIOCATH. AFTER VISUAL ANALYSIS OF THE PRODUCTS UNDER MAGNIFICATION, IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF SILICONE DROPLETS ON THE CATHETER THE BATCHES OF THE PACKAGED PRODUCT 6084422 AND THE ASSEMBLED SET BATCH 6060038 REFERRING TO THESE BATCHES, BUT WERE NO EVIDENCED RECORDS OF FOREIGN/NO FOREIGN MATTER IN THE PRODUCT. THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS OF FOREIGN AND NO FOREIGN MATTER FOR THE CLAIMED BATCHES. BASED ON THE INVESTIGATIONS CONDUCTED FOR CLAIMS OF EXCESS SILICONE OF ANGIOCATH, IT HAS BEEN FOUND THAT THE ROOT CAUSE OF THIS ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPING. FOR MORE DETAILS ON ROOT CAUSE CHECK (B)(4). THE (B)(4) THAT WAS OPENED TO TREAT THE CLOGGED NEEDLE COMPLAINTS OF THE ANGIOCATH IT WILL ALSO COVER THE COMPLAINTS OF EXCESS SILICONE OVER THE ANGIOCATH PRODUCT CATHETER, SINCE THE VALIDATIONS OF THE TIPPERS MACHINES WERE INCLUDED AMONG THE CORRECTIVE ACTIONS, WITH THE OBJECTIVE OF REDUCING THE AMOUNTS OF EXCESS SILICONE DISPENSED ON THE CATHETERS DURING THE CATHETER TIPPING PROCESS. THUS, IT IS BELIEVED THAT THE AMOUNT OF SILICONE THAT IS VISUALLY OBSERVED AS DROPLETS ON THE CATHETER WILL BE CONSIDERABLY REDUCED WHICH MAY RESULT IN IMPROVEMENT IN THE VISUAL ASPECT OF THE PRODUCT TO THE CUSTOMER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD ANGIOCATH¿ IV CATHETER 22G X 1.16 IN THE USER COMPLAINED THAT FOREIGN MATTER WAS FOUND ON THE CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771711 BD ANGIOCATH¿ IV CATHETER 22G X 1.16 IN INTRAVENOUS CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6084422 30382903811237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other