BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN

    MDR report key: 18049110 · Received November 1, 2023

    Report

    Report Number
    3014704491-2023-00684
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 13, 2023
    Report Date
    December 22, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830695
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#3080074): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(4) EA. 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED, AND THE DEFECT STATUS CANNOT BE CONFIRMED. 3. CHECK THE RETAINED SAMPLES OF THE COMPLAINT BATCH , NO COMPLAINT DEFECTS IS FOUND. PLEASE SEE ATTACHMENT FOR THE PHOTOS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE RETURNED, THE ROOT CAUSE OF THE CATHETER WITH BLACK DOTS AND BARBS, THE BLACK FOREIGN MATTER ON THE INNER WALL OF THE SHIELD, AND THE BROKEN OF THE PRN CANNOT BE DETERMINED, AND THE PLANT WILL CONTINUE TO FOLLOW UP ON THE COMPLAINT. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN HAD FOREIGN MATTER 9067277 - INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC-383069-FOREIGN MATTER-SUZHOU 1 WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE CATHETER HAD BLACK DOTS AND BARBS, THERE WAS BLACK FOREIGN MATTER ON THE INNER WALL OF THE NEEDLE GUARD CAP, THE HEPARIN CAP WAS BROKEN, GREEN CLAIM SETTLEMENT, COMPLAINT REPLY LETTER, COMPLAINT ACCEPTANCE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141268 BD INTIMA-II Y 22GAX1.00IN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080074 00382903830695

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown