BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD

    MDR report key: 8775409 · Received July 10, 2019

    Report

    Report Number
    1710034-2019-00738
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    May 16, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION, THE SEX OF THE PATIENT, WEIGHT OF THE PATIENT, AND DATE OF EVENT HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: A.3. SEX: FEMALE. A.4. WEIGHT: 8 POUNDS. B.3. DATE OF EVENT: (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THIS IS THE SECOND LOT TO HAVE POSSIBLY BEEN INVOLVED. D.4. MEDICAL DEVICE LOT #: 6158659, D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2019 AND H.4. DEVICE MANUFACTURE DATE: 6/6/2016. H.6. INVESTIGATION SUMMARY: RECEIVED ONE IAG 24GA NEEDLE COVER AND OPENED EMPTY PACKAGE FROM CATALOG NUMBER 381412, LOT NUMBER 7191659. IN ADDITION, WE RECEIVED ONE IAG 24GA OPENED EMPTY PACKAGE FROM CATALOG NUMBER 381412. THERE WAS ALSO A PIECE OF A BROKEN NEEDLE ATTACHED TO A PIECE OF TAPE IN THE BAG. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. VISUAL/MICROSCOPIC EVALUATION: THE PIECE OF A BROKEN NEEDLE DISPLAYED ; IT WAS THE TIP OF A NEEDLE WHICH WAS BROKE OFF AT THE NOTCH. CONCLUSION: INDETERMINATE: THE DEFECT CATHETER BROKE/SEPARATED AFTER PLACEMENT WAS IDENTIFIED AND CONFIRMED WITH THE RETURNED TIP OF THE NEEDLE. THE NEEDLE TIP CAN BREAK FROM THE WHEN BENT AT THE NOTCH; THIS IS THE WEAKEST AREA OF THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED A DAMAGED/DEFORMED/DEFECTIVE CATHETER TIP AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 7191659 PER PHONE CALL: CUSTOMER EXPLAINED THAT THE TIP OF THE CATHETER PORTION BROKE OFF POST-REMOVAL FROM PATIENT SO PATIENT UNAFFECTED. LOT # 7191659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED A DAMAGED/DEFORMED/DEFECTIVE CATHETER TIP AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 7191659. PER PHONE CALL: CUSTOMER EXPLAINED THAT THE TIP OF THE CATHETER PORTION BROKE OFF POST-REMOVAL FROM PATIENT SO PATIENT UNAFFECTED. LOT # 7191659.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD EXPERIENCED A DAMAGED/DEFORMED/DEFECTIVE CATHETER TIP AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 7191659. PER PHONE CALL: CUSTOMER EXPLAINED THAT THE TIP OF THE CATHETER PORTION BROKE OFF POST-REMOVAL FROM PATIENT SO PATIENT UNAFFECTED. LOT # 7191659.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571854 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6158659 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other