MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for PLEURX PERITONEAL CATHETER MINI KIT 50-9050 manufactured by Carefusion, Inc.
[119499977]
(b)(4). A follow up emdr will be submitted if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119499978]
When disconnecting the pleurx drain the white valve came away from the catheter. Causing the fluid to leak from the catheter. (b)(6) grabbed the white valve and put it back on the catheter and was able to continue to drain the patient. Pt was referred back to (b)(6) interventional radiology to have catheter replaced. The dr at (b)(6) said that it was draining just fine and that there was no need to replace catheter. So patient was sent home and continues to be drained approx every second day. Nurse contacted me because she is concerned that the valve may fall out again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2018-00040 |
| MDR Report Key | 7842457 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLEURX PERITONEAL CATHETER MINI KIT |
| Generic Name | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING |
| Product Code | PNG |
| Date Received | 2018-09-04 |
| Catalog Number | 50-9050 |
| Lot Number | 0001160341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-04 |