BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 8757842 · Received July 3, 2019

    Report

    Report Number
    9610847-2019-00443
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 18, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833239
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8093519. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THESE ISSUES OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. VISUAL EVALUATION OF THE RETURNED DEVICES IDENTIFIED THAT TWO OF THE THREE SUBMITTED, WERE SEMI-ACTIVATED AT THE TIME OF INVESTIGATION; LEAKAGE TESTING OF THE DEVICES DETERMINED THAT ONE DEVICE HAD SUFFERED A PUNCTURE THROUGH THE CATHETER TUBING NEAR THE TIP OF THE DEVICE. THIS PUNCTURE IS MOST LIKELY THE RESULT OF A PARTIAL OR SEMI-ACTIVATION OF THE DEVICE, WHICH PLACED THE TIP OF THE NEEDLE INTO THE NEEDLE SLEEVE, COMPROMISING THE INTEGRITY OF THE DEVICE. A REVIEW OF THE MANUFACTURING AND PACKAGING PROCESS WAS UNABLE TO IDENTIFY ANY NON-CONFORMANCE TO THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE SEMI-ACTIVATION OF THE DEVICE. ADDITIONALLY, THE DEVICE SUBMITTED TO OUR FACILITY WAS SUBJECTED TO OCCLUSION TESTING; OUR QUALITY ENGINEERS DETERMINED THAT THE DEVICE WAS BEING CLOGGED BY EXCESS SILICONE. THEY FURTHER DETERMINED THAT THE ROOT CAUSE FOR THIS EVENT IS RELATED TO MAINTENANCE ISSUES FOUND ON THE MANUFACTURING LINE ASSOCIATED WITH THE EQUIPMENT RESPONSIBLE FOR APPLYING THE SILICONE LUBRICANT TO THE NEEDLE. TO ADDRESS THIS ISSUE OUR FACILITY HAS INCREASED THE TIME TAKEN TO BLOW EXCESS SILICON OFF OF THE NEEDLE, MODIFIED THE PREVENTATIVE MAINTENANCE SCHEDULE FOR THE MACHINERY, AND REPAIRED THE MANUFACTURING EQUIPMENT. UNFORTUNATELY THE LEAKAGE THAT OCCURRED AT THE TUBING AFTER A FULL DAY OF USE COULD NOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS, DUE TO THE DEVICE OPERATING NORMALLY AT THE INITIAL TIME OF USE. FURTHER NONE OF THE DEVICES EXHIBITED SIGNS OF THIS TYPE OF LEAKAGE DURING THE COURSE OF OUR EVALUATION AND TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM'S HAD CLOGGED NEEDLES DURING USE WHILE PREPARING THE INJECTION, 3 CATHETERS WERE FOUND WITH THEIR NEEDLES THROUGH THEIR SHIELDS IN THEIR PACKAGING, AND A CATHETER SYSTEM HAD LEAKAGE OCCURRING FROM THE EXTENSION TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "NOTICED NEEDLE CLOGGED DURING THE PREPARATION OF INJECTION. DEFECTED PRODUCT DIDN¿T USED. NOTICED NEEDLE THROUGH SHIELD BEFORE UNWRAPPED THE PACKAGE. NOTICED EXT. TUBING LEAKY 1 DAY AFTER STARTING USAGE. NORMAL MEDICATION USED. NO PHYSICAL HARM TO THE PATIENT."

    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 THAT 3 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM'S HAD CLOGGED NEEDLES DURING USE WHILE PREPARING THE INJECTION, 3 CATHETERS WERE FOUND WITH THEIR NEEDLES THROUGH THEIR SHIELDS IN THEIR PACKAGING, AND A CATHETER SYSTEM HAD LEAKAGE OCCURRING FROM THE EXTENSION TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "NOTICED NEEDLE CLOGGED DURING THE PREPARATION OF INJECTION. DEFECTED PRODUCT DIDN¿T USE. NOTICED NEEDLE THROUGH SHIELD BEFORE UNWRAPPED THE PACKAGE. NOTICED EXT. TUBING LEAKY 1 DAY AFTER STARTING USAGE. NORMAL MEDICATION USED. NO PHYSICAL HARM TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554562 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8093519 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1 Other