FDA Adverse Event
Injury
Summary report: N
4 FR D/L POLY PICC WITH SAFETY MI IN UPFT
MDR report key: 2003842
·
Received February 24, 2011
Report
- Report Number
- 3006260740-2011-00051
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- January 13, 2011
- Report Date
- February 15, 2011
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K034019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
PICC LINE PLACED WITHOUT INCIDENT. CHEST X-RAY TWO DAYS LATER SHOWED WHAT APPEARED TO BE A WIRE AT THE END OF THE CATHETER. PATIENT WAS TAKEN TO CATH LAB AND A SMALL PIECE OF WIRE WAS REMOVED FROM THE END OF PICC. REQUIRED MEDICAL INTERVENTION. WIRE REMOVED WITHOUT DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 FR D/L POLY PICC WITH SAFETY MI IN UPFT | LJS | C. R. BARD INC. (BASD) | REUA0244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |