BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17579998 · Received August 18, 2023

    Report

    Report Number
    3014704491-2023-00476
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    August 6, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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: 31-AUG-2023 H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 3080077. 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, A SAMPLE WAS RETURNED TO OUR FACILITY TO AID IN OUR INVESTIGATION INTO THIS EVENT. VISUAL ANALYSIS OF THE DEVICE WAS ABLE TO IDENTIFY FOUR SEPARATE LOCATIONS OF DAMAGE OCCURRING TO THE CATHETER TUBING. THIS NONCONFORMANCE HAS BEEN CONFIRMED. CLOSER INSPECTION OF THE TUBING DAMAGE HAS IDENTIFIED CHARACTERISTICS THAT ARE INCONSISTENT WITH DAMAGE KNOWN TO OCCUR IN THE MANUFACTURING PROCESS, AND THE INITIAL SUCCESSFUL INTUBATION OF THE DEVICE SUGGESTS THAT THE DEVICE WAS OPERATING PROPERLY. DUE TO THE EXTENSIVE DAMAGE TO THE TUBING, FUNCTIONAL TESTING FOR TENSILE RESISTANCE WAS PERFORMED ON THE RETENTION SAMPLES FOR THIS LOT. THE TESTING RESULTS WERE CONSISTENT WITH PRODUCT STANDARDS. BASED ON THE AVAILABLE INFORMATION OUR PLANT COULD NOT ASSOCIATE THE EVENT WITH THE MANUFACTURING PROCESS AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE BROKE OFF/WAS BITTEN OFF BY THE CHILD PATIENT DURING USE. AS A RESULT, THE CHILD WAS TAKEN TO THE HOSPITAL FOR A HAND X-RAY, BUT THE NEEDLE WAS FOUND THE FOLLOWING DAY IN THE PATIENT'S BED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "PATIENT'S INDWELLING NEEDLE WAS FOUND BROKEN AT NIGHT AND THE NEXT DAY THE NEEDLE WAS FOUND DROPPED ON THE CHILD'S CLOTHES... RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE, AND THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: ON AUGUST 7TH, THE CHILD WENT HOME AFTER RECEIVING THE INDWELLING NEEDLE DURING THE DAY, AND SLEPT WITH THE NANNY AT NIGHT. THE CHILD HANDED THE INDWELLING NEEDLE TO THE NANNY AT 11 O'CLOCK IN THE EVENING, ONLY TO FIND THAT THE INDWELLING NEEDLE WAS BROKEN. LATER, HE WENT TO THE HOSPITAL TO TAKE A HAND X-RAY. A BROKEN NEEDLE WAS FOUND. ON THE MORNING OF (B)(6), A BROKEN INDWELLING NEEDLE WAS FOUND ON THE CHILD¿S BED. ACCORDING TO THE NANNY, XXXXX BIT IT OFF BY HIMSELF, BUT FOR SAFETY REASONS, HE TOOK THE BROKEN INDWELLING NEEDLE BACK AND PLANNED TO SEND IT BACK TO THE COMPANY FOR TESTING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE BROKE OFF/WAS BITTEN OFF BY THE CHILD PATIENT DURING USE. AS A RESULT, THE CHILD WAS TAKEN TO THE HOSPITAL FOR A HAND X-RAY, BUT THE NEEDLE WAS FOUND THE FOLLOWING DAY IN THE PATIENT'S BED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "PATIENT'S INDWELLING NEEDLE WAS FOUND BROKEN AT NIGHT AND THE NEXT DAY THE NEEDLE WAS FOUND DROPPED ON THE CHILD'S CLOTHES. RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE, AND THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: ON (B)(6), THE CHILD WENT HOME AFTER RECEIVING THE INDWELLING NEEDLE DURING THE DAY, AND SLEPT WITH THE NANNY AT NIGHT. THE CHILD HANDED THE INDWELLING NEEDLE TO THE NANNY AT 11 O'CLOCK IN THE EVENING, ONLY TO FIND THAT THE INDWELLING NEEDLE WAS BROKEN. LATER, HE WENT TO THE HOSPITAL TO TAKE A HAND X-RAY. A BROKEN NEEDLE WAS FOUND. ON THE MORNING OF (B)(6), A BROKEN INDWELLING NEEDLE WAS FOUND ON THE CHILD¿S BED. ACCORDING TO THE NANNY, XXXXX BIT IT OFF BY HIMSELF, BUT FOR SAFETY REASONS, HE TOOK THE BROKEN INDWELLING NEEDLE BACK AND PLANNED TO SEND IT BACK TO THE COMPANY FOR TESTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172327 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention