FDA Adverse Event
Injury
Summary report: N
HS BIOBLOC, 23 CM, ST. 14.5 FRENCH, IR
MDR report key: 2097792
·
Received April 12, 2011
Report
- Report Number
- 3006260740-2011-00136
- Event Type
- Injury
- Date Received
- April 12, 2011
- Report Date
- May 9, 2011
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K053589
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
THE LINE WAS PLACED AT ANOTHER FACILITY, PT CAME IN C/O PAIN. X-RAY FOUND THAT TIP OF CATHETER HAD BROKEN. CATHETER AND TIP HAVE BEEN REMOVED WITHOUT FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS BIOBLOC, 23 CM, ST. 14.5 FRENCH, IR | MSD | C. R. BARD INC. (BASD) | REUD0371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |