MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for PLEUR X DRAINAGE KIT DRAINAGE VACUM BOTTLE manufactured by Carefusion D.r. 203 Ltd.
[137368219]
Pleurx drainage bottle lost suction and the drain tubing dislodged from the base that punctures the bottle. The bottle needed to be discarded and a new kit opened to facilitate the drainage of the patients pleural catheter. The product was contaminated with pleural fluid, so it was discarded. The patients spouse stated that this is a routine occurrence when he does the drainage at home; he reports the issue to the company and they replace the defective product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084365 |
| MDR Report Key | 8371294 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-02-21 |
| Date Added to Maude | 2019-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | PLEUR X DRAINAGE KIT DRAINAGE VACUM BOTTLE |
| Generic Name | APPARATUS, SUCTION PATIENT CARE |
| Product Code | DWM |
| Date Received | 2019-02-25 |
| Lot Number | 00011255381 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION D.R. 203 LTD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-25 |