MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-11 for WAYNE PNEUMOTHORAX TRAY N/A C-UTPTY-1400-WAYNE-112497-IMH manufactured by Cook Inc.
[176805807]
Date of event: event occurred sometime in (b)(6) 2019. Occupation: risk manager. Report source: fda 3500a 3600840000-2019-8016. 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
[176805808]
It was reported that after a pigtail insertion for larger right sided pleural effusion, a guide wire in the wayne pneumothorax tray stripped apart. An (b)(6) year old male presented with a large, right-sided pleural effusion on the first post-operative day for a coronary artery bypass grafting (cabg) and aortic valve replacement. When the guide wire was being pulled out of the pigtail chest tube, it became stuck within the catheter. When the doctor pulled the guide wire harder, it "stripped apart". The entire chest tube was removed, and an x-ray confirmed that the device was removed intact from the patient after the wire had stripped. No other adverse effects have been reported for this incident. Additional information regarding patient and event details have been requested, but have not been made available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02819 |
| MDR Report Key | 9304691 |
| Report Source | OTHER |
| Date Received | 2019-11-11 |
| Date of Report | 2019-11-11 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2019-11-11 |
| 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 Contact | MR. LARRY POOL |
| 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 | 2019-11-11 |
| Model Number | N/A |
| Catalog Number | C-UTPTY-1400-WAYNE-112497-IMH |
| Lot Number | 9651454 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-11-11 |