BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10107348 · Received June 1, 2020

    Report

    Report Number
    1710034-2020-00343
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814672
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED THE FOLLOWING UNUSED UNOPENED UNITS: (B)(4) UNITS FROM LOT 9225178, 17 UNITS FROM LOT 9119988, (B)(4) UNITS FROM LOT 8318966, (B)(4) UNIT FROM LOT 8212900 AND (B)(4) UNIT FROM LOT 9031615. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. THROUGH OUR INVESTIGATION THE UNITS WERE ALL INSPECTED FOR OVERLAPPING SPRINGS, DAMAGE TO THE GRIP OR BARREL, BENT CANNULAS AND/OR EXCESSIVE GEL. NO DEFECTS WERE OBSERVED. A FUNCTIONAL TEST WAS THEN PERFORMED WHERE ALL UNITS SUCCESSFULLY RETRACTED INSTANTLY UPON PRESSING THE BUTTON. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS FROM LOT# 9119988, 1 CATHETER FROM LOT# 8212900, 1 CATHETER FROM LOT# 9031615, 29 CATHETERS FROM LOT# 8318966, AND 61 CATHETERS FROM LOT# 9225178 WOULD NOT RETRACT THEIR NEEDLE WHEN THEIR BUTTON WAS PRESSED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PRODUCT IS BD INSYTE AUTOGUARD 14GA IV NEEDLE. SOME OF OUR STAFF NOTICED THAT WHEN THE RETRACT BUTTON IS PUSHED THE NEEDLE DOES NOT RETRACT. IT STICKS INSIDE THE CATHETER CREATING A SAFETY ISSUE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9119988, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2019-04-29. MEDICAL DEVICE LOT #: 8212900, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2018-07-31. MEDICAL DEVICE LOT #: 9031615, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2019-01-31. MEDICAL DEVICE, LOT #: 8318966. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2018-11-14.EDICAL DEVICE LOT #: 9225178, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-08-13. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 15 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS FROM LOT# 9119988, 1 CATHETER FROM LOT# 8212900, 1 CATHETER FROM LOT# 9031615, 29 CATHETERS FROM LOT# 8318966, AND 61 CATHETERS FROM LOT# 9225178 WOULD NOT RETRACT THEIR NEEDLE WHEN THEIR BUTTON WAS PRESSED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PRODUCT IS BD INSYTE AUTOGUARD 14GA IV NEEDLE. SOME OF OUR STAFF NOTICED THAT WHEN THE RETRACT BUTTON IS PUSHED THE NEEDLE DOES NOT RETRACT. IT STICKS INSIDE THE CATHETER CREATING A SAFETY ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568361 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381467 SEE SECTION H.10. 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other