MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-05-28 for PLEURX PLEURAL CATHETER AND STARTER KIT 50-7700 manufactured by Carefusion, Inc.
[146235575]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). No sample or lot available at this time.
Patient Sequence No: 1, Text Type: N, H10
[146235576]
Patient came to stormont complaining of pain with drainage and leakage of the catheter. (could not specify if the leakage was coming from the catheter exit site or the valve. The catheter could not be determined if the leak was coming from not draining properly and subsequent build up of fluid or the valve itself). Inspection of the valve looked fine during visit and valve damage from the rocket bottle could not be determined at this time. Patient also was complaining that the catheter was not draining. During the visit with the patient we were told the home health nurse was using rocket medical bottles. The home health was told by medline these bottles were compatible with the pleurx system. The patient said the bottles would not drain the catheter. He also experienced a lot of pain with drainage and their control button did not work and therefore the pain persisted. They then said they received a "pleurx brand bottle" from the hospital and the catheter worked well and drained as planned. The home health has begun using pleurx bottles and the patient has not returned to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00041 |
| MDR Report Key | 8645892 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-05-28 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-06-14 |
| 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 AND STARTER KIT |
| Generic Name | APPARATUS, SUCTION, PATIENT CARE |
| Product Code | DWM |
| Date Received | 2019-05-28 |
| Catalog Number | 50-7700 |
| 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. Hospitalization | 2019-05-28 |