BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 21057101 · Received January 2, 2025

    Report

    Report Number
    3002601200-2025-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 11, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    UNK
    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. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4081488 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAY 2024, AND PACKAGED AT R240 PACKAGE LINE IN MAY 2024. 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 DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO ABNORMALITY IS FOUND. PLEASE REFER TO THE ATTACHMENT FOR INSPECTION REPORT. 4. CAUSE ANALYSIS: 1-IN THE ACTUAL PACKAGING PROCESS, THE PRODUCT IS MANUALLY PLACED INTO THE PACKAGING CAVITY BY THE OPERATOR. IF THE STEEL NEEDLE BENDS AND PUNCTURES THE SHIELD, THE OPERATOR IS UNABLE TO OPERATE. 2-ABNORMAL CONDITIONS MAY OCCUR DURING TRANSPORTATION OR STORAGE, THE PRODUCT MAY BE SQUEEZED, RESULTING IN THE COMPLAINED DEFECTS. 5. 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, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER EXAMINATION AND ANALYSIS, THE ROOT CAUSE OF NEEDLE BENT AND STEEL NEEDLE THROUGH SHIELD CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND SUCH ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM NEEDLE THROUGH SHIELD. THE NURSE WAS PREPARING TO USE THE INDWELLING NEEDLE FOR THE PATIENT'S INFUSION WHEN SHE UNPACKED THE BAG AND FOUND THAT THE INDWELLING NEEDLE WAS BENT AND UNUSABLE, AND THEN IMMEDIATELY REPLACED IT. NEW INFORMATION RECEIVED 09DEC2024. THE NURSE USED THE INDWELLING NEEDLE WHEN PREPARING TO INFUSE THE PATIENT. UPON OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE INDWELLING NEEDLE WAS BENT, AND THE STEEL NEEDLE HAD PIERCED THE NEEDLE TIP COVER, RENDERING IT UNUSABLE. THE SAMPLE IN QUESTION WAS DISCARDED AT THE TIME AND CANNOT BE RETRIEVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322955 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081488 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown