BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN

    MDR report key: 15253064 · Received August 18, 2022

    Report

    Report Number
    8041187-2022-00475
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 25, 2022
    Report Date
    September 20, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1230280 MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026 DEVICE MANUFACTURE DATE: 18-AUG-2021 MEDICAL DEVICE LOT #: 1274750, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026, DEVICE MANUFACTURE DATE: 01-OCT-2021, MEDICAL DEVICE LOT #: 2087453, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027, DEVICE MANUFACTURE DATE: 28-MAR-2022. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NINE SAMPLES IN OPEN PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. (B)(4)UNITS WERE RECEIVED FROM BATCH 1230280 AND (B)(4) UNITS FROM BATCH 1274750. NO SAMPLE WAS RECEIVED FROM BATCH 2087453. FOR BATCH 1230280, SAMPLES 1 AND 3 UNDER 20X MAGNIFICATION, SMALL DROPLETS OF TRANSPARENT, GEL-LIKE SUBSTANCES WERE OBSERVED ON THE SURFACE OF THE CATHETER TUBING, HOWEVER, THE LUBRICANT APPEARANCE WAS FOUND TO BE ACCEPTABLE. FOR SAMPLES 2 AND 5 UNDER 20X MAGNIFICATION, A SMALL LUMP OF TRANSPARENT, GEL-LIKE SUBSTANCE WAS OBSERVED ON THE SURFACE OF THE CATHETER TUBING, HOWEVER, THE LUBRICANT APPEARANCE WAS FOUND TO BE ACCEPTABLE. FOR SAMPLE 4 UNDER 20X MAGNIFICATION, A PIECE OF SOLIDIFIED LUBE WAS OBSERVED WAS OBSERVED ON THE CATHETER TUBING NEAR THE CATHETER TIP. FOR BATCH 1274750 THE SAMPLES WERE VIEWED UNDER 20X MAGNIFICATION, SMALL DROPLETS OF TRANSPARENT, GEL-LIKE SUBSTANCES WERE OBSERVED ON THE SURFACE OF THE CATHETER TUBING, HOWEVER, THE LUBRICANT APPEARANCE WAS FOUND TO BE ACCEPTABLE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE EVALUATION OF THE RETURNED SAMPLES, THE SMALL DROPLETS / LUMPS OF TRANSPARENT GEL-LIKE SUBSTANCES 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 ALL THE RETURNED SAMPLES WERE FOUND TO BE ACCEPTABLE, EXCEPT FOR SAMPLE 4 FROM BATCH 123280. FOR THIS SAMPLE, SMALL LUMPS OF TRANSPARENT LUBE GEL WERE ALSO OBSERVED ON THE CATHETER TUBING. GIVEN THE IRREGULAR SHAPE OF THE SOLIDIFIED LUBE, IT WAS SUSPECTED THAT THE USER MIGHT HAVE UNINTENTIONALLY SCRATCHED THE SURFACE OF THE CATHETER TUBING DURING NEEDLE COVER REMOVAL, HENCE THE AGGREGATED THE LAYER OF EXCESSIVE LUBE TO FORM THE SOLIDIFIED LUBE. AS THE SAMPLE WAS RETURNED IN OPEN PACKAGING, AN ACTUAL ROOT CAUSE CANNOT BE ESTABLISHED. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 23 BD ANGIOCATH PLUS¿ I.V. CATHETERS 20GA X 1.16IN, THERE WAS SILICONE OVERFLOW IN CATHETER TUBE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SILICONE OVERFLOW IN CATHETER TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 23 BD ANGIOCATH PLUS¿ I.V. CATHETERS 20GA X 1.16IN, THERE WAS SILICONE OVERFLOW IN CATHETER TUBE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SILICONE OVERFLOW IN CATHETER TUBE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026341 BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown