FDA Adverse Event
Injury
Summary report: N
3 FR S/L PER-Q-CATH PLUS INTERMEDIATE TRAY
MDR report key: 2041983
·
Received March 31, 2011
Report
- Report Number
- 3006260740-2011-00093
- Event Type
- Injury
- Date Received
- March 31, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 7, 2011
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K954104
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT OF THE CATHETER BEING OCCLUDED (THROMBOSIS) IS INCONCLUSIVE. RETURNED FOR EVALUATION ARE SEVEN UN-OPENED 3 FR S/L PQC PLUS TRAYS. ONE OF THE TRAYS WAS OPENED AND THE CATHETER WAS REMOVED. DURING FUNCTIONAL TESTING THE CATHETER WAS FOUND PATENT TO INFUSION. THE COMPLAINT INCIDENT COULD NOT BE CONFIRMED, BASED ON SEVEN UN-OPENED PQC KITS. THIS TYPE OF CLINICAL SITUATION CANNOT BE REPLICATED IN THE LAB. THE PRODUCTS INSTRUCTIONS FOR USE (IFU) INDICATES THAT VENOUS THROMBOSIS IS A POTENTIAL COMPLICATION. A CHR OF LOT #REUL0444 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
VESSEL THROMBOSIS OCCURRED WITHIN 24 HOURS OF PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3 FR S/L PER-Q-CATH PLUS INTERMEDIATE TRAY | LJS | C. R. BARD, INC. (BASD) | REUL0444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |