MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-01-29 for WAYNE PNEUMOTHORAX TRAY C-UTPTY-1400-WAYNE-112497-IMH manufactured by Cook Inc.
[177369546]
Pma/510(k) #: exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[177369547]
It was reported that the guidewire in a wayne pneumothorax tray was found to be broken upon removal. The product failed upon initial placement during a thoracostomy procedure to drain a hemothorax. The device was placed in the right anterior chest, 4th intercostal space, to drain bodily fluid. The catheter was placed and resistance was felt upon removing the guidewire. When pulled out, it was found to be broken. After the guide wire was observed to be broken, "the straightening trocar was removed". The catheter "never drained blood", so a second device was successfully used in its place. No adverse effects to the patient have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00233 |
| MDR Report Key | 9643631 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-12-04 |
| Date Added to Maude | 2020-01-29 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAYNE PNEUMOTHORAX TRAY |
| Generic Name | JOL CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2020-01-29 |
| Model Number | NA |
| Catalog Number | C-UTPTY-1400-WAYNE-112497-IMH |
| Lot Number | 10158554 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |