MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-05-28 for PLEURX PLEURAL CATHETER MINI KIT 50-7050 manufactured by Carefusion, Inc.
[146346783]
(b)(4) initial 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. Without a sample, photograph or lot information the investigation was unable to confirm the failure mode nor identify a probable root cause. As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint. This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.
Patient Sequence No: 1, Text Type: N, H10
[146346784]
The customer reported: i want to inform you about a defective valve. At first the nose was broken off, then later on it was noticed that the valve is leaking. The valve was changed. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00040 |
| MDR Report Key | 8645676 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-05-28 |
| 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 | 3 |
| Brand Name | PLEURX PLEURAL CATHETER MINI KIT |
| Generic Name | APPARATUS, SUCTION, PATIENT CARE |
| Product Code | DWM |
| Date Received | 2019-05-28 |
| Catalog Number | 50-7050 |
| 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 | 2019-05-28 |