BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6789021 · Received August 11, 2017

    Report

    Report Number
    1710034-2017-00131
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    July 17, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. CUSTOMER PHOTOS WERE SUBMITTED. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. 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). PR #: (B)(4)- MDR PHOTO PART #: 381412 - 24 G X 0.75 IN. (0.7 MM X 19 MM) BD INSYTE AUTOGUARD SHIELDED IV CATHETER. MADE OF BD VIALON CATHETER BIOMATERIAL. HAS BD INSTAFLASH NEEDLE TECHNOLOGY. LOT #: 7101565. COMPLAINT: NEEDLE RETRACTION FAILURE . EVENT DESCRIPTION: RN WAS USING A 24G REGULAR. WHEN SHE HIT THE BUTTON K IT ONLY PARTIALLY RETRACTED, THEN GOT STUCK. I WANTED TO EMAIL YOU ABOUT THE PIV CATHETER MALFUNCTION THAT OCCURRED IN OUR ED. ATTACHED IS A PICTURE AND IT HAS BEEN OCCURRING SOMEWHAT FREQUENTLY. LET ME KNOW WHAT THE NEXT STEPS WOULD BE. 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 CONDUCTED. LOT 7101565 WAS BUILT ON (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 CODES WAS AN S2 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THE LEVEL A INVESTIGATION; AS A RESULT OF THE REVIEW THERE WERE NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECTS STATED IN THE PR ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. OBSERVATIONS AND TESTING: ALTHOUGH A SAMPLE WAS NOT PROVIDED FOR OBSERVATIONS AND TESTING; PHOTOS WERE PROVIDED: PHOTO REVEALED: THE UNIT WAS A 24G BD INSYTE AUTOGUARD WHICH CONSISTED OF THE NEEDLE/HUB ASSEMBLY THAT WAS PARTIALLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL). THE BUTTON WAS COMPLETELY DEPRESSED AND HAD TRACES OF A RED SUBSTANCE. THERE WAS ALSO A VIEW OF A TOP WEB (LID) FROM A BD INSYTE AUTOGUARD (24GA X 0.75 IN). OBSERVED THERE WAS DAMAGE TO THE GRIP WHERE THE END OF NEEDLE/HUB WAS OBSERVED. THE DAMAGED GRIP WAS IDENTIFIED AS THE SOURCE THAT RESTRICTED THE NEEDLE FROM FULLY RETRACTING. TEST DESCRIPTION: METHOD NO: RESULTS: VISUAL/MICROSCOPIC ; N/A ; SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, EVALUATION OF THE PHOTO PROVIDED FOR THIS INCIDENT REVEALED DAMAGE TO THE GRIP THAT HINDERED THE NEEDLE FROM FULLY RETRACTING. INVESTIGATION CONCLUSION: CONCLUSIONS: CONFIRMATION OF THE SUBJECT OF NEEDLE RETRACTION FAILURE, AS STATED IN THE PR, WAS IN CONCLUSIVE BASED ON THE EVALUATION OF THE PHOTO PROVIDED FOR THIS INCIDENT. THE PHOTO DISPLAYED DAMAGE TO THE GRIP COMPONENT WHICH HINDERED A FULL RETRACTION OF THE NEEDLE INTO THE BARREL UPON ACTIVATION. THIS WAS PHYSICAL/MECHANICAL 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 NEEDLE RETRACTION FAILURE WAS CONCLUSIVE BASED ON THE OBSERVATIONS OF THE PHOTO PROVIDED FOR THIS INCIDENT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? N/A: UNITS WERE NOT PROVIDED FOR THIS INCIDENT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE DESCRIPTION: ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING ¿ THE CAUSE OF THE RETRACTION FAILURE REPORTED IN THIS PR WAS DAMAGE TO THE GRIP. COMMENT: THE PLUG PROBE AND THE LOAD BARREL STATIONS IN ZONE 5 HAVE THE ABILITY TO BECOME MISALIGNED AND PRODUCE THE TYPE OF DAMAGE OBSERVED IN THE RETURNED SAMPLE. WHEN THERE IS A MISALIGNMENT, THE PROBE INADVERTENTLY CONTACTS THE EDGE OF THE GRIP AND CAUSES THE DAMAGE OBSERVED IN THE COMPLAINT SAMPLE. 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. MANUFACTURING WAS NOTIFIED OF THIS INCIDENT AND THE FINDINGS. THE PEURA (END USER RISK ANALYSIS) RM5835 REV 11 VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A RN WAS USING A 24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, SHE HIT THE SAFETY RETRACTION BUTTON. HOWEVER, THE SAFETY MECHANISM ONLY PARTIALLY RETRACTED, RESULTING IN A NEEDLE STICK. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568635 24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7101565

    Patients

    Seq Age Sex Outcome Treatment
    1 Other