MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-28 for ATRAUM AXIOM ANGLE SILICONE CATHETER 36 FRENCH STOP CLOT N/A 111136AT manufactured by Axiom Medical Inc..
[927]
Resident removed chest tube easily. Distal portion of chest tube broke at the angulation and remained in chest. Surgical intervention was required to remove portion of chest tube from chest. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3689 |
| MDR Report Key | 3689 |
| Date Received | 1992-07-28 |
| Date of Report | 1992-04-30 |
| Date of Event | 1992-04-22 |
| Date Facility Aware | 1992-04-22 |
| Report Date | 1992-04-30 |
| Date Reported to Mfgr | 1992-04-30 |
| Date Added to Maude | 1993-04-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRAUM AXIOM ANGLE SILICONE CATHETER 36 FRENCH STOP CLOT |
| Generic Name | CHEST TUBE |
| Product Code | FEZ |
| Date Received | 1992-07-28 |
| Model Number | N/A |
| Catalog Number | 111136AT |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3435 |
| Manufacturer | AXIOM MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-28 |