MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for PLEURX PERITONEAL CATHETER MINI KIT 50-9050 manufactured by Carefusion, Inc.
[136611201]
(b)(4) initial/final emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). No sample was returned for analysis. Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis. A device history record review could not be completed as no batch number was provided. Based on the limited results of the complaint investigation, a probable root cause could not be identified since no complaint sample was submitted for evaluation and no lot information was provided for review. Since no probable root cause was identified, the investigation was not able to identify any corrective or preventive actions for this complaint. This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences through the quality data analysis process.
Patient Sequence No: 1, Text Type: N, H10
[136611202]
Disconnected valve. When putting on the clothes, the valve disconnected from the catheter. The safety clamp was used and the valve was changed. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00001 |
| MDR Report Key | 8282096 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-01-09 |
| Date Added to Maude | 2019-01-28 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| 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 | 2019-01-28 |
| Catalog Number | 50-9050 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-01-28 |