FDA Adverse Event
Injury
Summary report: N
4 FR S/L POLY RADPICC WITH 70 CM PLATINUM TIP GUIDE
MDR report key: 2042015
·
Received March 31, 2011
Report
- Report Number
- 3006260740-2011-00094
- 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
- K034019
- 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 EVAL ARE SIX SAME LOT NUMBER UN-OPENED 4 FR S/L POLY RADPICC TRAYS. THE COMPLAINT INCIDENT COULD NOT BE CONFIRMED, BASED ON SIX UN-OPENED RADPICC 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 #REUL0108 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
VESSEL THROMBOSIS OCCURRED WITHIN 24 HOURS PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 FR S/L POLY RADPICC WITH 70 CM PLATINUM TIP GUIDE | LJS | C. R. BARD INC. (BASD) | REUL0108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |