BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRO SAFETY ARTERIAL CATHETER

    MDR report key: 15316955 · Received August 29, 2022

    Report

    Report Number
    2243072-2022-01420
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 2, 2022
    Report Date
    November 27, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN MANUFACTURER NAME, CITY AND STATE AND MFR SITE AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER AS DELTAMED IS AN OEM MANUFACTURING SITE. AN INVALID LOT #: (1110343) WAS PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 21-SEP-2022. H6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110343. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE 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. ADDITIONALLY, 35 SAMPLES ALONG WITH A VIDEO DISPLAY A LEAKING UNIT WERE SUBMITTED TO AID IN OUR INVESTIGATION. BASED ON THE VIDEO EVIDENCE, OUR ENGINEERS WERE ABLE TO CONFIRM THE OCCURRENCE OF LEAKAGE BUT WERE UNABLE TO MAKE OUT ANY CHARACTERISTICS THAT WOULD INDICATE A SPECIFIC ROOT CAUSE. THE SUBMITTED SAMPLES WERE ALSO SUBJECTED TO FUNCTIONAL TESTING FOR PENETRATION FORCE, CATHETER KINKING , AND LEAK DETECTION, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS AND WERE FREE OF ANY OBSERVABLE NON CONFORMANCES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OR REPLICATE THE REPORTED NON-CONFORMANCE OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER IS KINKING DURING USE OF BD PRO SAFETY ARTERIAL CATHETER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: KINKING OF THE CANNULA IS ENCOUNTERED AT THE MOMENT OF REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER IS KINKING DURING USE OF BD PRO SAFETY ARTERIAL CATHETER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: KINKING OF THE CANNULA IS ENCOUNTERED AT THE MOMENT OF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299560 BD PRO SAFETY ARTERIAL CATHETER ARTERIAL CATHETER FOZ BECTON DICKINSON UNKNOWN - SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown