MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for UNKNOWN manufactured by Cook Inc.
[146225798]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[146225799]
It was reported the patient had a right lung biopsy prior to being discharged from the hospital. After the biopsy a chest x-ray was ordered, but the patient was discharged from the hospital prior to the chest x-ray being read. The x-ray showed a small pneumothorax. The patient was contacted and came in for a repeat chest x-ray. That x-ray showed a larger pneumothorax and the decision was made to place a chest tube. The patient was admitted through ambulatory surgical unit in order to be sedated for the procedure. The patient came to interventional radiology (ir) and a right chest tube was inserted. The chest tube was then attached to the chest drain valve. A follow up chest x-ray showed near 90% pneumothorax. The patient immediately brought to ir by the x-ray technician. The physician evaluated the patient and found that the chest drain valve was reversed. The valve was immediately removed and patient was placed on 20 cm of suction. A repeat chest x-ray showed only 10% residual pneumothorax. The patient was then transferred. It was further reported "upon investigation, the instructions for the device were on a clear type of paper with print almost impossible to visualize. Both ends of the valve fit into the chest tube. The device should not be able to be reversed. The potential for injury is too great. " as reported, there were no adverse outcomes to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01308 |
| MDR Report Key | 8641200 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-08-19 |
| Date Mfgr Received | 2019-08-05 |
| Date Added to Maude | 2019-05-24 |
| 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 | 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 | 0 |
| Product Code | KDQ |
| Date Received | 2019-05-24 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 1. Required No Informationntervention | 2019-05-24 |