BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 7059531 · Received November 27, 2017

    Report

    Report Number
    1710034-2017-00423
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 20, 2017
    Report Date
    December 4, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814442
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    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). INVESTIGATION COMPLETED BY: (B)(6), PR #: (B)(4), MDR- NO SAMPLE. PART #: 381844 ¿ 18 G X 1.16 IN. (1.3 MM X 30 MM) BD INSYTE AUTOGUARD SHIELDED IV CATHETER. MADE OF BD VIALON CATHETER BIOMATERIAL. LOT #: 7192991. COMPLAINT: NEEDLE RETRACTION FAILURE. EVENT DESCRIPTION: AFTER HAVING PIERCED THROUGH THE SKIN OF THE PATIENT AND PUT THE CATHETER, WHEN PUSHING ON THE SAFETY MECHANISM, BUTTON NOTHING HAPPENS, THE NEEDLE DOESN'T RETRACT. 2 PERSONS TRIED AND NONE SUCCEEDED. 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: RESULTS OF THIS REVIEW DISCLOSED: THIS LOT (7192991) WAS BUILT ON AFA LINE 8 ON 19MAR2017 THROUGH 26MAR2017 AND PACKAGED ON LINE 11 FOR THE QUANTITY OF (B)(4). PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED TO) FOR DAMAGED COMPONENT (GRIP, BUTTON, SPRING, HUB), NEEDLE RETRACTION BY BUTTON ACTIVATION AND ADHESIVE OVERFILLED/DRIP AS WELL AS PERIODIC CLEANING/ALIGNMENT OF THE GLUE GRIPPERS WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. 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. OBSERVATIONS AND TESTING: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: UNKNOWN; UNITS WERE NOT RECEIVED FOR OBSERVATION AND TESTING. PEURA ANALYSIS: THE PEURA (END USER RISK ANALYSIS) (B)(4) VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. INVESTIGATION CONCLUSIONS: CONFIRMATION OF THE DEFECT STATED IN THE PR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECTS STATED IN THE PIR. THIS INCIDENT IS INDETERMINATE. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? N/A; UNABLE TO CONFIRM THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT RETURNED FOR EVALUATION AND TESTING. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? N/A; UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT RETURNED FOR EVALUATION AND TESTING. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE DESCRIPTION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. CORRECTIVE ACTION PROJECT / CAPA (#): A ROOT CAUSE COULD NOT BE ESTABLISHED. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETRACTION BUTTON FAILED TO RETRACT THE BD INSYTE¿ AUTOGUARD¿ NEEDLE AFTER HAVING PIERCED THE PATIENT¿S SKIN. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839044 BD INSYTE¿ AUTOGUARD¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7075699 00382903814442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other