BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 6880500 · Received September 20, 2017

    Report

    Report Number
    1710034-2017-00200
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 31, 2017
    Report Date
    November 11, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED / AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY THE DESIGNATED COMPLAINT HANDLING UNIT (DCHU). COMPLAINT: FOREIGN MATTER. EVENT DESCRIPTION: UNIDENTIFIABLE ITEM WITHIN UNOPENED PACK OF INSYTE AUTOGUARD BLOOD CONTROL SEE ATTACHED IMAGES. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: LOT 7080832; WAS BUILT AND PACKAGED ON AFA LINE 11 ON 24MAR 2017 FOR THE QUANTITY OF (B)(4). REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PR. 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 THE MDR - LEVEL A INVESTIGATION; AS A RESULT OF THE REVIEW THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE PR ASSOCIATED WITH THE POTENTIAL LOT NUMBERS PROVIDED FOR THIS INCIDENT. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: ALTHOUGH UNITS WERE NOT RECEIVED FOR INVESTIGATION; PHOTOS WERE PROVIDED FOR OBSERVATION OF THIS INCIDENT. ONE PHOTO REVEALED A SEALED PACKAGE FROM REF. # (B)(4), LOT # 7080832. THE REMAINING FOUR PHOTOS REVEALED A 22G BD IAG BC IV CATHETER UNIT WITHIN THE SEALED PACKAGE WHICH HAD FM AT THE GRIP AND BARREL OF THE UNIT. VISUAL/MICROSCOPIC EXAMINATION: THE FM HAD A BROWNISH/BLACKISH DISCOLORATION TO IT. IT COULD NOT BE DETERMINED IF THE FM WAS BURNT RESIN (NON-FOREIGN) OR GREASE (FM). *NOTE: ALTHOUGH WITHOUT THE ACTUAL UNIT FOR OBSERVATIONS AND TESTING IT COULD NOT BE DETERMINED IF THE FM WAS EMBEDDED OR NOT AND THE SOURCE COULD NOT BE DEFINITELY IDENTIFIED; YET IT WAS CONFIRMED BECAUSE THE UNIT WAS WITHIN A SEALED PACKAGE THAT THE FM WAS SOMEHOW MANUFACTURING RELATED. TEST DESCRIPTION METHOD NO RESULTS VISUAL/MICROSCOPIC, N/A, SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, FM WAS NOTED TO BE ON THE GRIP AND BARREL OF THE UNIT WITHIN A SEALED PACKAGE. INVESTIGATION CONCLUSION: CONCLUSIONS: CONFIRMATION OF THE SUBJECT OF FOREIGN MATTER, AS STATED IN THE PR, WAS CONCLUSIVE WITH THE OBSERVATIONS OF THE PHOTOS PROVIDED FOR THIS INCIDENT. CONFIRMED THERE WAS A BROWNISH/BLACKISH SUBSTANCE ON THE GRIP AND BARREL OF THE UNIT WITHIN A SEALED PACKAGE; WHICH WAS PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES: CONFIRMATION OF THE FAILURE OF FOREIGN MATTER WAS CONCLUSIVE WITH THE OBSERVATION OF THE PHOTOS PROVIDED FOR THIS INCIDENT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE OF FM WAS NOT NECESSARY AS THE REPORTED DEFECT WAS CONFIRMED AND THE UNIT WAS NOT PROVIDED. ROOT CAUSE DESCRIPTION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING - ALTHOUGH FM WAS CONFIRMED AND NOTED TO BE MANUFACTURING RELATED A DEFINITE SOURCE COULD NOT BE DETERMINED AND THE FM COULD NOT BE IDENTIFIED WITHOUT THE ACTUAL DEFECT UNIT FOR OBSERVATION AND TESTING. MANUFACTURING WILL BE NOTIFIED OF THIS INCIDENT AND FINDINGS. RATIONALE: CORRECTIONS AND CAPA CORRECTIVE ACTION PROJECT / CAPA (#): A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED 22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL HAD UNIDENTIFIABLE MATTER WITHIN THE UNOPENED INSYTE AUTOGUARD PACK. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658174 22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7080832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other