MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for WAYNE PNEUMOTHORAX TRAY C-UTPTY-1400-WAYNE-112497-IMH manufactured by Cook, Inc..
[128029103]
A 14. 0fr catheter (wayne pneumothorax tray, cook medical, (b)(4), usa) was placed for treatment of pneumothorax. The catheter obturator, a stiffening device used to aid catheter insertion, was not removed as intended following insertion of the catheter. This appropriate device function for drainage of a pneumothorax. The healthcare provider recognized the error within approximately 30 minutes and removed the obturator, restoring device function. The device design facilitates this error, because the obturator unnecessarily includes a connector at its proximal tip, allowing it to be connected to the external drainage system. We have previously reported this problem to fda and the device mfr when the same form of error was committed by different healthcare providers in a different patient. Left unrecognized, this error could be fatal to a patient or could result in the need for additional medical procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081424 |
| MDR Report Key | 8080096 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-09-22 |
| Date Added to Maude | 2018-11-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WAYNE PNEUMOTHORAX TRAY |
| Generic Name | CANNULA CATHETER |
| Product Code | DQR |
| Date Received | 2018-11-15 |
| Model Number | C-UTPTY-1400-WAYNE-112497-IMH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-15 |