BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 10610905 · Received September 30, 2020

    Report

    Report Number
    1710034-2020-00628
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 7, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM). (B)(4). INVESTIGATION SUMMARY: DHR FOR LOT 0111315; HAS BEEN REVIEWED. THE LOT WAS BUILT AND PACKAGED ON AFA LINE 12 FROM 26APR2020 THROUGH 30APR2020 FOR THE QUANTITY OF 528,010 UNITS. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. INCOMING INSPECTION RECORDS WERE REVIEWED FOR THE CANNULA LOTS 9189424, 9317643, 9317642, 0044744 AND 9189420. NO QUALITY ISSUES OR PROCEDURAL DEVIATIONS WERE FOUND. DEURA (B)(4) HAS BEEN REVIEWED. BEVEL ALIGNMENT WITH THE NOTCH IS IDENTIFIED AS A POTENTIAL CAUSE OF POOR FLASHBACK ON P.7. HOWEVER, THIS CAUSE HAS BEEN PROVEN TO HAVE NO EFFECT ON THE FLASHBACK (AS INDICATED BY SNDY350-SF75 FOR THE ECG NOTCH FOR 22 AND 24 GAUGE AUTOGUARD CANNULA). REQUEST TO CORRECT RM5255 HAS BEEN SUBMITTED TO THE UNIT QA. INVESTIGATION CONCLUSION: RECEIVED 8 UNUSED 22GA BD INSYTE AUTOGUARD BLOOD CONTROL IV CATHETER UNITS WITHIN UNDAMAGED PACKAGES FROM REF. 382523, LOT 0111315: 3 ARE SEALED PACKAGES AND 5 ARE OPENED PACKAGES. THE NEEDLES FOR ALL RETURNED UNITS REVEAL TO HAVE NO ANOMALIES OR DAMAGE (I.E. BENDS, BURRS, FLASH, DEFORMATION, ETC.). PER BUY SPECIFICATION A1590RM, REV4, POSITION OF THE NOTCH IS NOT EVALUATED. THIS IS BECAUSE THE DRAWING DWG 404048 REV5, STATES: NOTES 16. NO ORIENTATION IS REQUIRED BETWEEN THE BEVEL AND THE NOTCH FOR ECG-GROUND NOTCHES. INCOMING INSPECTION RECORDS REVIEWED REVEALED NO QUALITY ISSUES FOR THE CANNULA LOTS USED IN THE MANUFACTURING OF THE FINAL PRODUCT LOT UNDER THIS INVESTIGATION. THREE OF THE RETURNED UNITS DO NOT HAVE THE NOTCH ALIGNED WITH THE BEVEL. ALTHOUGH THE NOTCH ON SEVERAL OF THE RETUNED UNITS ARE NOT ORIENTED WITH THE BEVEL OF THE CANNULA, THIS IS NOT CONSIDERED A DEFECT. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS, HOWEVER THE NEED FOR A FORMAL CORRECTIVE ACTION CANNOT BE DETERMINED IN THE ABSENCE OF THE ROOT CAUSE. RISK TO THE END USER IS ESTABLISHED BASED ON OCCURRENCE AND SEVERITY OF THE DEFECT AS RELATED TO A SPECIFIC FAILURE MODE IN THE MANUFACTURING PROCESS AND THE EFFECTS OF THAT FAILURE. THE RISK COULD NOT BE EVALUATED FOR THE UNCONFIRMED DEFECT IN THE ABSENCE OF THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 382523, BATCH NO. 0111315. HOLE BUILT ON TOP OF NEEDLE (DESIGNED FOR FLASH OF BLOOD RETURN IN CATHETER) IS CUT IMPROPERLY INTO NEEDLE (SOME CUTS ARE ON BACK OF NEEDLE OR ON SIDE- SHOULD BE TOP MATCHING BEVEL AND WHITE RETRACTOR BUTTON).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069392 SEE H10 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0111315 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other