BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2018-00280
- Event Type
- Malfunction
- Date Received
- June 13, 2018
- Date of Event
- May 16, 2018
- Report Date
- September 7, 2018
- 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
- HK
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER: 7180634. THE PRODUCT WAS BUILT ON AFA LINE 10, FROM JULY 3, 2017 THRU JULY 5, 2017. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. 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. IN PROCESS INSPECTIONS FOR FOREIGN/NON-FOREIGN MATERIAL, PARTICULATE LOOSE OR EMBEDDED WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. QN / SAP DATABASE REVIEW FINDINGS: THERE WERE NO 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: RECEIVED ONE UNUSED IAG 22GA UNIT WITH NO PACKAGE FROM THE LOT NUMBER 7180634. THE UNIT CONSISTED OF THE CATHETER/ADAPTER INSIDE OF THE NEEDLE COVER. VISUAL/MICROSCOPIC EXAMINATION: WHITE FM WAS PRESENT AT THE TIP THE CATHETER TUBING. THE FM WAS IDENTIFIED TO BE NON-FOREIGN (POROUS PLUG SHAVINGS). THE POROUS PLUG SHAVINGS (NON-FOREIGN) EXCEEDED 0.2 SQUARE MILLIMETERS MEASURED PER TAPPI DIRT ESTIMATION CHART. CONCLUSIONS: THE DEFECT OF FOREIGN MATTER, STATED IN THE DESCRIPTION OF THE COMPLAINT, WAS CONFIRMED WITH THE RETURNED UNIT. CONFIRMED THE FOREIGN MATTER WAS A NON-FOREIGN (POROUS PLUG SHAVINGS) THAT IS A MATERIAL OF CONSTRUCTION USED IN THE MANUFACTURING PROCESS. 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.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.
IT WAS REPORTED THAT FOREIGN PARTICLE WAS FOUND ON THE SURFACE OF THE CATHETER OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT FOREIGN PARTICLE WAS FOUND ON THE SURFACE OF THE CATHETER OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
(B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT FOREIGN PARTICLE WAS FOUND ON THE SURFACE OF THE CATHETER OF A BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441825 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 7180634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |