FDA Adverse Event
Malfunction
Summary report: N
23 CM STRAIGHT HEMOSPLIT STANDARD KIT
MDR report key: 2801219
·
Received October 17, 2012
Report
- Report Number
- 3006260740-2012-00370
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- October 3, 2012
- Report Date
- October 8, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K030020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
IT IS REPORTED THAT AFTER THE ROUTINE DIALYSIS WAS COMPLETED, THE NURSE FOUND THE BLOOD LEAKED BADLY FROM THE CATHETER TRANSPARENT TUBING MARKED "A" AND NOTICED THERE IS A FRACTURE PARALLELED WITH THE TUBING. THE DEVICE WAS REMOVED OUT OF PATIENT AND A NEW SET WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 23 CM STRAIGHT HEMOSPLIT STANDARD KIT | MSD | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |