MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-21 for PLEURX PLEURAL CATHETER AND STARTER KIT 50-7700 manufactured by Carefusion, Inc.
[136733592]
(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
[136733593]
Physician was removing a pleurx on a patient that broke. The catheter came out but the cuff remained in the patient. A surgeon had to be called in to remove the cuff from the patient. On 1feb2019: additional info from (b)(6), sale's rep: the physician was removing the catheter as it was no longer needed. During removal, the catheter broke, leaving the cuff in place. A surgeon was able to remove the remaining piece and the patient is currently doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00010 |
| MDR Report Key | 8357483 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-21 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-01-31 |
| 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 AND STARTER KIT |
| Generic Name | APPARATUS, SUCTION, PATIENT CARE |
| Product Code | DWM |
| Date Received | 2019-02-21 |
| Catalog Number | 50-7700 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |