FDA Adverse Event
Injury
Summary report: N
23 CM 14.5 FR HEMOSTAR STANDARD KIT
MDR report key: 2121048
·
Received June 9, 2011
Report
- Report Number
- 3006260740-2011-00186
- Event Type
- Injury
- Date Received
- June 9, 2011
- Date of Event
- May 11, 2011
- Report Date
- June 3, 2011
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K051748
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT CATHETER WAS INSERTED ON (B)(6) 2011 BY THE RADIOLOGIST, AFTER THE CATHETER WAS INSERTED THE RADIOLOGIST NOTICED BLEEDING FROM THE A PORT LINE. THEY HAD TO DO ANOTHER REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 23 CM 14.5 FR HEMOSTAR STANDARD KIT | MSD | C. R. BARD INC. (BASD) | REVA0354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |