MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for COOK CHEST TUBE, 14 FRENCH MAC-LOC manufactured by Cook Incorporated.
[179956322]
The patient's chest tube hub snapped off from the pigtail itself, revealing the wires and disconnecting the patient from suction. The remaining pigtail was immediately clamped and service was called. Service came to bedside and decided to fully remove the chest tube, as there was no way to reconnect the tube to suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9726535 |
| MDR Report Key | 9726535 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-01 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-02-19 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CHEST TUBE, 14 FRENCH MAC-LOC |
| Generic Name | CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2020-02-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 1100 W MORGAN ST SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |