FDA Adverse Event
Malfunction
Summary report: N
HEMOGLIDE KIT
MDR report key: 1230857
·
Received October 28, 2008
Report
- Report Number
- 3006260740-2008-00180
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- September 30, 2008
- Report Date
- October 3, 2008
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K010567
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE IS A HOLE IN THE CATHETER, BETWEEN THE BIFURCATION AND THE CUFF. DISCOVERED DURING ONGOING DIALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOGLIDE KIT | MSD | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |