FDA Adverse Event
Malfunction
Summary report: N
27 CM STRAIGHT HEMOSPLIT STANDARD KIT
MDR report key: 2191466
·
Received July 27, 2011
Report
- Report Number
- 3006260740-2011-00259
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- May 26, 2011
- Report Date
- July 6, 2011
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K030020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
DATE OF PLACEMENT IS NOT KNOWN, A LEAK AT THE BIFURCATION WAS NOTED ON (B)(6) 2011. LINE REMOVED AND REPLACED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 27 CM STRAIGHT HEMOSPLIT STANDARD KIT | MSD | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |