FDA Adverse Event
Injury
Summary report: N
POLY PER-Q-CATH 5 FR D/L BASIC
MDR report key: 1140938
·
Received August 28, 2008
Report
- Report Number
- 3006260740-2008-00103
- Event Type
- Injury
- Date Received
- August 28, 2008
- Report Date
- August 6, 2008
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K031129
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE REPORT OF DEEP VEIN THROMBOSIS (DVT) IS INCONCLUSIVE DUE TO THE NATURE OF THE COMPLAINT. THE COMPLAINANT ALLEGED AN INCREASE OF DVT WITH THE USE OF THE 5 FR D/L POLY PQC PICC. ONE UNUSED CATHETER WAS RETURNED FOR EVAL. NO VISUAL DAMAGE, FOREIGN MATERIAL, OR DEFECTS WERE NOTED ON THE TUBING. THE PROBLEM CANNOT BE REPLICATED IN THE LAB. THE EXACT CAUSE OF THE REPORTED INCIDENTS IS UNKNOWN. A CHR OF LOT #RERI0331 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT.
Description of Event or Problem · 1
THE FACILITY HAS SEEN 16 CONFIRMED DVTS, MUCH MORE THAN THEY HAD WITH PREVIOUS PRODUCTS. ANALYSIS OF EACH CASE HAD COME TO THE CONCLUSION THAT THE INCREASE IN DVTS IS RELATED TO THEIR INSERTION TECHNIQUE; HOWEVER, COMPLAINANT DENIES ANY PRACTICE CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLY PER-Q-CATH 5 FR D/L BASIC | LJS | C. R. BARD INC. (BASD) | RERI0331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |