MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2019-02-21 for PLEURX PLEURAL CATHETER MINI KIT 50-7050 manufactured by Carefusion, Inc.
[136752300]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136752301]
Whilst removing the catheter tip from the indwelling catheter a? Hiss? Was heard. This isn? T usually heard whilst performing this task. Concern that the one way valve is faulty. Indwelling pleural catheter inserted (b)(6) 2018. The valve? Hisses? Air when the access tip is removed from the catheter. Fluid doesn? T leak through. No air is heard when the catheter cap is removed, only after drainage. New catheter inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00013 |
| MDR Report Key | 8357811 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2019-02-21 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-02-21 |
| 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 | 2019-02-21 |
| Catalog Number | 50-7050 |
| Lot Number | 0001236839 |
| 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. Required No Informationntervention | 2019-02-21 |