MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for PLEURX 50-7510 manufactured by Carefusion 2200, Inc.
[119344515]
Product did not reach patient. Product opened by nurse. Drainage line and plunger found unattached from drainage bottle. Visual inspection of 2 more unopened drainage kits from same lot found. Drainage line unattached from drainage bottle on 2nd kit and, retaining clip unattached from drainage bottle on 3rd kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7850219 |
| MDR Report Key | 7850219 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-08-21 |
| Report Date | 2018-08-22 |
| Date Reported to FDA | 2018-08-22 |
| Date Reported to Mfgr | 2018-09-06 |
| Date Added to Maude | 2018-09-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURX |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | PNG |
| Date Received | 2018-09-06 |
| Model Number | 50-7510 |
| Catalog Number | 50-7510 |
| Lot Number | 001233048 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DR VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |