BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7553848 · Received May 30, 2018

    Report

    Report Number
    1710034-2018-00245
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 30, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814542
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW WAS CONDUCTED WHICH DISCLOSED THE FOLLOWING: LOT 7201989 WAS BUILT ON AFA LINE 6 FROM 26JUL2017 THRU 30JUL2017 AND PACKAGED ON PKG. LINE 8 FROM FOR THE QUANTITY OF 208,810EA. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND 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. REVIEW DISCLOSED THERE WERE NO RELATED 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 EVENT DESCRIPTION. NO SIGNIFICANT DISCOVERIES WERE FOUND. SAP (QN) DATABASE REVIEW WAS CONDUCTED FOR THE MDR-LEVEL A INVESTIGATION; AS A RESULT OF THE REVIEW THERE WERE NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE PIR ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING: ALTHOUGH A SAMPLE WAS NOT RETURNED A PHOTO WAS PROVIDED FOR EVALUATION OF THIS INCIDENT. THE PHOTO REVEALED A USED IAG UNIT WHICH CONSISTED OF THE NEEDLE/HUB ASSEMBLY PARTIALLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL) WITH THE ACTIVATION BUTTON COMPLETELY DEPRESSED. THERE WERE TRACES OF MEDIA PRESENT ON THE UNIT. THE PHOTO DID NOT REVEAL SUFFICIENT EVIDENCE TO IDENTIFY ANY TYPE OF SPECIFIC DAMAGE TO THE UNIT THAT WOULD HINDER A FULL/SUCCESSFUL RETRACTION/SHIELDING. FURTHER OBSERVATIONS FOR DAMAGE (I.E. SCUFF MARKINGS, STRESS MARKINGS, DAMAGED BARREL, DAMAGED GRIP, ETC.) COULD NOT BE CONDUCTED WITHOUT THE ACTUAL SAMPLE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OF NEEDLE SHIELDING FAILURE AS SEEN IN THE PHOTO; THEREFORE THE ROOT CAUSE OF THIS INCIDENT IS INDETERMINATE. THE PHOTO DID NOT DISPLAY SUFFICIENT EVIDENCE TO IDENTIFY ANY TYPE OF SPECIFIC DAMAGE TO THE UNIT THAT WOULD HINDER A FULL/SUCCESSFUL RETRACTION/SHIELDING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DID NOT COMPLETELY RETRACT, AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INITIAL REPORTER ALSO NOTIFIED THE FDA (B)(6) 2018. MEDWATCH REPORT # (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DID NOT COMPLETELY RETRACT, AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394540 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7201989 30382903814542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other