MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-09-09 for PLEURAFLOW SYSTEM PF-32 manufactured by Clearflow Inc.
[25697383]
Evaluation summary: physical inspection was conducted on (b)(6) 2015. The clearance wire assembly of the device showed significant deformation inconsistent with normal use. External forces, the nature of which is unknown at this time, may have caused the damage. Additional analysis is pending.
Patient Sequence No: 1, Text Type: N, H10
[25697384]
The clearance loop portion of the pleuraflow system separated from the clearance wire and remained inside the guide tube portion of the device. The guide tube is external to the patient and connects the chest tube to the drainage canister. The guide tube was removed and the chest tube remained and continued draining.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2015-00002 |
| MDR Report Key | 5070191 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-09 |
| Date of Event | 2015-07-31 |
| Date Mfgr Received | 2015-08-11 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-09-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1630 S SUNKIST ST. STE E |
| Manufacturer City | ANAHEIM CA 92806 |
| Manufacturer Country | US |
| Manufacturer Postal | 92806 |
| Manufacturer Phone | 7149165014 |
| Manufacturer G1 | XERIDIEM |
| Manufacturer Street | 4700 SOUTH OVERLAND DR. |
| Manufacturer City | TUCSON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLEURAFLOW SYSTEM |
| Generic Name | POWERED SUCTION PUMP, OTK, GBX |
| Product Code | OTK |
| Date Received | 2015-09-09 |
| Returned To Mfg | 2015-08-24 |
| Model Number | PF-32 |
| Lot Number | 8962-04 |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARFLOW INC |
| Manufacturer Address | 1630 S SUNKIST ST STE E ANAHEIM CA 928060000 US 928060000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-09 |