MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-27 for LIFE-PORT NI 7513 manufactured by Stratto-medical.
[627]
Distal tip of cath broke off at the subclavian venous junction. The distal portion of the cath tip is located in the right atrium. Patient was transported to cumberland memorial hospital where, under fluoroscopy, the cath tip was removed successfully. Personnel in radiology discarded the distal tip of the devicedevice 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, other. Results of evaluation: component failure, port. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1025 |
| MDR Report Key | 1025 |
| Date Received | 1992-07-27 |
| Date of Report | 1992-07-17 |
| Date of Event | 1992-07-09 |
| Date Facility Aware | 1992-07-09 |
| Report Date | 1992-07-17 |
| Date Reported to FDA | 1992-07-17 |
| Date Reported to Mfgr | 1992-07-17 |
| Date Added to Maude | 1992-08-03 |
| 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 | LIFE-PORT |
| Generic Name | UNKNOWN |
| Product Code | LKG |
| Date Received | 1992-07-27 |
| Model Number | NI |
| Catalog Number | 7513 |
| Lot Number | 119203 |
| ID Number | NI |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-SEP-91 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 981 |
| Manufacturer | STRATTO-MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-27 |