BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) ANGIOCATH

    MDR report key: 6751954 · Received July 28, 2017

    Report

    Report Number
    9610048-2017-00010
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    July 3, 2017
    Report Date
    August 16, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    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

    ¿THE FOLLOWING WERE RETURNED FOR EVALUATION: ONE UNUSED UNIT IN A SEALED PACKAGE FROM CATALOG NUMBER 381112, LOT NUMBER 6084421. ONE UNUSED UNIT IN AN OPENED PACKAGE AND TWO UNUSED UNITS WITHOUT PACKAGES FROM CATALOG NUMBER 381112, LOT NUMBER 6111320. NINE UNUSED REPRESENTATIVE SAMPLES IN SEALED PACKAGES FROM CATALOG NUMBER 381112, LOT NUMBER 6111320. PHOTOS OF THE REPORTED DEVICE. A VISUALLY/MICROSCOPIC INSPECTION OF THE RETURNED SAMPLES FOUND SILICONE DROPLETS ON THE CATHETER TUBING ON ALL OF THE RETURNED UNITS. THE SILICONE IS A MEDICAL GRADE SILICONE THAT THE CATHETERS ARE DIPPED IN TO AID IN THE EASE OF INSERTION AND IS NOT HARMFUL TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBERS 6111320 AND 6084421 REVEALED NO EXCESS SILICONE IN THE TESTS CARRIED OUT DURING THE PRODUCTION. ADDITIONALLY, THERE WERE NO QUALITY NOTIFICATIONS FOR THIS REPORTED DEFECT. CONCLUSION: THE ROOT CAUSE IS EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING SILICONIZATION OF THE CATHETER IN THE TIPPER MACHINES. CAPA # (B)(4) HAS BEEN CREATED. 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6111320; MEDICAL DEVICE EXPIRATION DATE: 03/31/2021; DEVICE MANUFACTURE DATE: 05/06/2016; MEDICAL DEVICE LOT #: 6084421; MEDICAL DEVICE EXPIRATION DATE: 03/31/2021; DEVICE MANUFACTURE DATE: 04/07/2016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEAR LUMP OF FOREIGN MATTER WAS FOUND ON THE CATHETER TIP OF A 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532699 24G X 0.75IN (0.7 X 19 MM) ANGIOCATH INTERVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other