MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-17 for WAYNE PNEUMOTHORAX SET N/A C-UTPT-1400-WAYNE-112497-IMH manufactured by Cook Inc.
[183735541]
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
[183735542]
It was reported a wayne pneumothorax catheter had disconnected between the vinyl connecting tube and the 3-way tap when a nurse was emptying the patient's drain. The nurse had tightened the connection herself, but it disconnected overnight. The vinyl connecting tube that disconnected is a component of the set. It disconnected where the vinyl connecting tube luer-locks into the 3-way tap. The nurse reported it was easy to luer lock the connector to the tap and that it was a tight connection, "so it un-luer-locked itself even after it was tightened". After the disconnection, the patient went into respiratory distress and a code blue was called. The staff reconnected the connecting tube, the patient was given oxygen, and suction was applied to the drainage catheter. A chest x-ray was performed and the pneumothorax was noted to be slightly larger than before. The device has now been removed from the patient and the patient is reported to be doing "okay". When asked about how the device was secured to the patient, the nurse reported "we do not add any additional securing tapes to the connection at the 3 way tap. We do however tape the tubing to the patients skin with a fixation dressing as per manufacturer recommendation". No other adverse effects have been reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03134 |
| MDR Report Key | 9482410 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-17 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2019-12-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 SET |
| Generic Name | JOL CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2019-12-17 |
| Returned To Mfg | 2020-01-06 |
| Model Number | N/A |
| Catalog Number | C-UTPT-1400-WAYNE-112497-IMH |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2019-12-17 |