MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-10 for WAYNE PNEUMOTHORAX TRAY N/A C-UTPTY-1400-WAYNE-112497-IMH manufactured by Cook Inc.
[175752536]
Occupation: clinical research manager. 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
[175752537]
It was reported that upon insertion into the left lateral chest (4th intercostal space), the guidewire of a wayne pneumothorax tray frayed, resulting in fragmentation. All fragments were able to be retrieved from the patient. There was difficulty reported in getting the wire out. A new device was required and obtained. It was reported that the "incision was made at the anterior axillary line" and that the device was left in place for a "minimal" period of time. The wire was attempted to be removed through the needle, but then frayed and had to be removed with the needle. It was also reported that "she had to pull out both at the same time. The frayed piece was still attached to the main wire so it all came out together. " no additional fragments were visualized. No adverse effects to the patient have been reported. Additional information regarding the patient, device, and event have been requested but are unavailable at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03070 |
| MDR Report Key | 9444674 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-10 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-10-14 |
| Date Added to Maude | 2019-12-10 |
| 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 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 | 2019-12-10 |
| Returned To Mfg | 2019-12-09 |
| Model Number | N/A |
| Catalog Number | C-UTPTY-1400-WAYNE-112497-IMH |
| Lot Number | 10055716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-10 |