MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for WAYNE PNEUMOTHORAX TRAY C-UTPTY-1400-WAYNE-112497 manufactured by Cook Inc.
[131002573]
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[131002574]
The following information was reported: the heimlich valve could be inserted the wrong way because it fit on the "wrong" side. It was further noted that the complainant did not think the ifu (instructions for use) for the wayne pneumothorax tray was written clearly. It stated "insert in direction of arrow" and was embossed in clear plastic so it was easily missed. It referred to a connection to a chest drain, but the terminology could have meant the pleurevac or the actual catheter. This product problem did not result in any reported serious injuries to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03813 |
| MDR Report Key | 8175745 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2018-12-18 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| 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 | 0 |
| Brand Name | WAYNE PNEUMOTHORAX TRAY |
| Generic Name | DQR CANNULA, CATHETER |
| Product Code | DQR |
| Date Received | 2018-12-18 |
| Model Number | NA |
| Catalog Number | C-UTPTY-1400-WAYNE-112497 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-18 |