FDA Adverse Event
Malfunction
Summary report: N
POWERGROSHONG WITH SHERLOCK 5F SINGLE-LUMEN SILICONE CATH
MDR report key: 3181968
·
Received June 17, 2013
Report
- Report Number
- 3006260740-2013-00308
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 28, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K063848
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REWD0335 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT PICC INSERTED ON (B)(6) 2013. LEAKING DURING CHEMO INFUSION AT 34 CM MARK. PICC REMOVED. IT WAS LEAKING CHEMOTHERAPY SUBCUTANEOUSLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274355 | POWERGROSHONG WITH SHERLOCK 5F SINGLE-LUMEN SILICONE CATH | LJS | C. R. BARD INC. (BASD) | REWD1602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |