BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7060332 · Received November 27, 2017

    Report

    Report Number
    1710034-2017-00393
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 26, 2017
    Report Date
    January 16, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHRS ARE AVAILABLE FOR REVIEW AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. FINDINGS: MDR: REVIEW WAS PREVIOUSLY CONDUCTED FOR PR (B)(4). RESULTS OF THIS REVIEW DISCLOSED: THIS LOT (7192991) WAS BUILT ON AFA LINE 1, FROM APRIL 13, 2017 THRU APRIL 18, 2017. PER REVIEW IT WAS OBSERVED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS S-AU33, S-AU34, S-AU35, AND S-AU36, IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. MRR / SAP-QN DATABASE REVIEW: YES. REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY. FINDINGS: SUBJECT CODE WAS AN S1 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION; AS A RESULT OF THE REVIEW THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE PIR ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE ROOT CAUSE IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A NEEDLE RETRACTION FAILURE OF THE 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841393 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7097679 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other