MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-29 for N/A P4341A manufactured by Baxter Healthcare Corporation.
[803]
Patient was undergoing a thoracentesis. Upon removal of the catheter a 3-4 cm section of the catheter was noted to be missing. A chest xray was done immediately. Chest tube was placed and the foreign object was removed under fluoroscopydevice labeled for single use. Patient medical status prior to event: invalid data. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown, incorrect technique/procedure. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 823 |
| MDR Report Key | 823 |
| Date Received | 1992-06-29 |
| Date of Report | 1992-06-10 |
| Date of Event | 1992-04-24 |
| Date Facility Aware | 1992-04-24 |
| Report Date | 1992-06-10 |
| Date Reported to FDA | 1992-06-10 |
| Date Reported to Mfgr | 1992-05-22 |
| Date Added to Maude | 1992-07-02 |
| 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 | N/A |
| Generic Name | THORACENTESIS CATHETER |
| Product Code | IPT |
| Date Received | 1992-06-29 |
| Model Number | N/A |
| Catalog Number | P4341A |
| 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 | 791 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-06-29 |