BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2018-00610
- Event Type
- Injury
- Date Received
- August 27, 2018
- Date of Event
- August 8, 2018
- Report Date
- October 30, 2018
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903815129
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: NO UNITS OR PHOTOS WERE PROVIDED FOR OBSERVATION AND/OR TESTING OF THIS INCIDENT THEREFORE THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED. WITHOUT A SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #87102817 REGARDING ITEM #381512. DHR REVIEW FOR LOT 7102817; WAS PREVIOUSLY CONDUCTED FOR (PR (B)(4) CR) WHICH DISCLOSED THE FOLLOWING: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AUTOGUARD LINE 4 STARTING ON APRIL 19, 2017 THROUGH APRIL 23, 2014 AND PACKAGED ON LINE 10 ON APRIL 23, 2017 THROUGH MAY 1, 2017. ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED. SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) ADAPTER DAMAGED-DEFORMED AND DAMAGED COMPONENT PASSED PER SPECIFICATION. NEEDLE RETRACTION BY BUTTON ACTIVATION WAS PERFORMED AT VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. SAP (QN) DATABASE REVIEW; WAS CONDUCTED FOR THIS INVESTIGATION, WHICH DISCLOSED THE FOLLOWING: THERE WERE NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. ONE NON-RELATED IP QN (B)(4) FOR LEAKAGE (CATHETER TUBING) WAS INITIATED FOR THIS LOT: DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. 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. 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. 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.
IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH NEEDLE STICK INJURY AND FAILED RETRACTION. NEEDLE DID NOT RETRACT AND EMPLOYEE WAS STUCK BY EXPOSED NEEDLE.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH NEEDLE STICK INJURY AND FAILED RETRACTION. NEEDLE DID NOT RETRACT AND EMPLOYEE WAS STUCK BY EXPOSED NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658909 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTERVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 7102817 | 30382903815129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |