MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-22 for STOPCOCK 9 IN EXTENSION manufactured by Argon Medical Corp..
[22570]
Facility changed cvp pressure set up. Prior to change, waveform was good. After change, facility noted a leak at the fast flush connector. Set was disconnected, 2nd set put up and it caused the monitor to blank out. Biomed researched monitor and checked system and found no malfunction with system. 2nd set discontinued and entire pressure set replaced. 3rd set working fine, good cvp waveform present. Tubing sets 1 & 2 given to nurse manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31891 |
| MDR Report Key | 31891 |
| Date Received | 1996-03-22 |
| Date of Report | 1996-03-08 |
| Date of Event | 1996-03-08 |
| Date Facility Aware | 1996-03-08 |
| Report Date | 1996-03-13 |
| Date Reported to FDA | 1996-03-13 |
| Date Added to Maude | 1996-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOPCOCK 9 IN EXTENSION |
| Generic Name | STOPCOCK |
| Product Code | KRK |
| Date Received | 1996-03-22 |
| Lot Number | 95125843 |
| Device Expiration Date | 1996-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33035 |
| Manufacturer | ARGON MEDICAL CORP. |
| Manufacturer Address | ATHENS TX 75751 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-22 |