BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7930670 · Received October 3, 2018

    Report

    Report Number
    1710034-2018-00710
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 11, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEWS; WERE CONDUCTED FOR THIS INVESTIGATION WHICH DISCLOSED THE FOLLOWING: LOT 7282722; WAS MANUFACTURED ON AFA LINE 6 ON (B)(6) 2017 THROUGH (B)(6) 2017 AND PACKAGED ON PKG. LINE 8 FROM (B)(6) 2017 THROUGH (B)(6) 2017 FOR THE QUANTITY OF (B)(4) EA. THERE WAS ONE NON-RELATED TEMPORARY DEVIATION (TD-2017-60 ¿WEEKLY MAINTENANCE; PERFORMED ANY DAY MON. THRU FRI. ON EITHER DAY OR NIGHT SHIFT¿) WERE IN AFFECT DURING THE BUILD OF THIS LOT. ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. LOT 7268945; WAS MANUFACTURED ON AFA LINE 6 STARTING ON (B)(6) 2017 THROUGH (B)(6) 2017 AND PACKAGED ON PKG. LINE 8 FROM (B)(6) 2017 THROUGH (B)(6) 2018 FOR THE QUANTITY OF (B)(4). THERE WAS ONE NON-RELATED TEMPORARY DEVIATION (TD-2017-60 ¿WEEKLY MAINTENANCE; PERFORMED ANY DAY MON. THRU FRI. ON EITHER DAY OR NIGHT SHIFT¿) WERE IN AFFECT DURING THE BUILD OF THIS LOT. ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. LOT 7222624; WAS MANUFACTURED ON AFA LINE 6 STARTING ON 16AUG2017 THROUGH 18AUG2017 AND PACKAGED ON PKG. LINE 8 FROM (B)(6) 2017 THROUGH (B)(6) 2017 FOR THE QUANTITY OF (B)(4). THERE WERE TWO NON-RELATED TEMPORARY DEVIATIONS (TD 2017-77 ¿RATIONAL SAMPLING PER BLITZ #917-SET-UP SAMPLING MUST BE PERFORMED BEFORE STARTING PRODUCTION¿) AND (TD-2017-60 ¿WEEKLY MAINTENANCE; PERFORMED ANY DAY MON. THRU FRI. ON EITHER DAY OR NIGHT SHIFT¿) WERE IN AFFECT DURING THE BUILD OF THIS LOT. ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. NO SAMPLES OR PHOTOS WERE PROVIDED FOR THIS INCIDENT. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE -NO UNITS OR PHOTOS WERE PROVIDED FOR OBSERVATION AND/OR TESTING OF THIS INCIDENT THEREFORE THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD PACKAGING SEAL FAILURE WHICH COMPROMISED THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7282722, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2017-10-09. MEDICAL DEVICE LOT #: 7268945, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31 , DEVICE MANUFACTURE DATE: 2017-09-25. MEDICAL DEVICE LOT #: 7222624, MEDICAL DEVICE EXPIRATION DATE: 2020-07-31, DEVICE MANUFACTURE DATE: 2017-08-10. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD PACKAGING SEAL FAILURE WHICH COMPROMISED THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773349 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other