BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS¿ I.V. CATHETER

    MDR report key: 15387640 · Received September 8, 2022

    Report

    Report Number
    8041187-2022-00529
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 24-AUG-2022. INVESTIGATION SUMMARY: TEN SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. SEVEN SAMPLES OF BATCH 9202390 WERE RECEIVED AND WERE LABELED AS #1 TO #7. SAMPLES 1, 2, AND 3 WERE WITHOUT PACKAGING, SAMPLES 4 AND 5 WERE RECEIVED IN OPEN PACKAGING, AND SAMPLES 6 AND 7 WERE RECEIVED WITH SEALED PACKAGING. THESE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR EXCESSIVE SILICONE ON THE CATHETER. FOR SAMPLES 1 AND 2, NO VISIBLE LUMP OR DROPLET OF TRANSPARENT, GEL-LIKE SUBSTANCE WAS OBSERVED ON THE CATHETER TUBING. INSTEAD, A ¿V-CUT¿ WAS OBSERVED NEAR THE CATHETER TIP. FOR SAMPLE 3, NO VISIBLE LUMP OR DROPLET OF TRANSPARENT, GEL-LIKE SUBSTANCE WAS OBSERVED ON THE CATHETER TUBING. INSTEAD, THE CANNULA WAS OBSERVED TO PIERCE THROUGH THE CATHETER. A BLOOD STAIN WAS ALSO OBSERVED ON THE SAMPLE. FOR SAMPLES 4, 5, AND 6, UNDER 20X MAGNIFICATION, SMALL LUMPS OF TRANSPARENT, GEL-LIKE SUBSTANCE, WAS OBSERVED ON THE SURFACE OF THE CATHETER TUBING. HOWEVER, THE LUBRICANT APPEARANCE WAS FOUND TO BE ACCEPTABLE. FOR THE USED SAMPLE 3, THE NEEDLE PIERCING THROUGH THE CATHETER WAS OBSERVED. THE ASSEMBLY PROCESS WAS REVIEWED, IF THE NEEDLE PIERCED THROUGH THE CATHETER DURING THE MANUFACTURING PROCESS, THE DEFECT WOULD BE DETECTED AND AUTO REJECTED BY THE 100% INLINE TIP SPEAR VISION INSPECTION SYSTEM. THE NEEDLE PIERCING THROUGH THE CATHETER COULD OCCUR DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED, OR DURING NEEDLE COVER REMOVAL. AS THE SAMPLES WERE EITHER RETURNED WITHOUT PACKAGING OR USED, AN ACTUAL ROOT CAUSE COULD NOT BE ESTABLISHED. FOR SAMPLES 4 TO 7 OF BATCH 9202390, THE SMALL DROPLETS / LUMPS OF TRANSPARENT, GEL-LIKE SUBSTANCES WERE OBSERVED ON THE CATHETER TUBING WERE MOST LIKELY EXCESSIVE LUBRICANT THAT AGGREGATED AND FORMED SMALL DROPLETS / LUMPS ON THE CATHETER SURFACE. GIVEN THE GEL-LIKE NATURE OF THE LUBE, IT WAS POSSIBLE FOR THE LUBRICANT TO FLOW TO DIFFERENT LOCATIONS ON THE CATHETER DURING TRANSPORTATION OR STORAGE. THE LUBRICANT APPEARANCE ON THESE RETURNED SAMPLES WERE FOUND TO BE ACCEPTABLE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE 3 BD ANGIOCATH PLUS¿ I.V. CATHETER EXPERIENCED THE SILICONE OVERFLOWED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH SILICONE OVERFLOW IN CATHETER TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 3 BD ANGIOCATH PLUS¿ I.V. CATHETER EXPERIENCED THE SILICONE OVERFLOWED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH. SILICONE OVERFLOW IN CATHETER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108338 BD ANGIOCATH PLUS¿ I.V. CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9202390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown