FDA Adverse Event
Malfunction
Summary report: N
19 CM 14.5 FR HEMOSTAR STANDARD KIT
MDR report key: 2892530
·
Received December 26, 2012
Report
- Report Number
- 3006260740-2012-00472
- Event Type
- Malfunction
- Date Received
- December 26, 2012
- Date of Event
- November 30, 2012
- Report Date
- December 3, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K051748
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. LOT HISTORY REVIEW (LHR) LOT # REVK0143. LOT SIZE (# OF UNITS RELEASED TO DISTRIBUTION): 885. SIMILAR COMPLAINT RECORDS: 421474. QUANTITY AFFECTED (THIS AND SIMILAR COMPLAINTS): 1. COMPLAINT THRESHOLD (BASED ON LOT SIZE AND SEVERITY): 2.
Description of Event or Problem · 1
HEMOSTAR WAS INSERTED ON (B)(6) 2012 AND USED FOR HEMODIALYSIS. CATHETER MIGRATED OUT OF THE INSERTED TRACK ON CHEST WALL, BUT CUFF REMAINED INGROWN IN TISSUE. CATHETER BECAME SEPARATED FROM CUFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 19 CM 14.5 FR HEMOSTAR STANDARD KIT | MSD | C. R. BARD INC. (BASD) | REVK0143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |