MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for manufactured by Arrow International.
[3086]
Two rn,s turned patient after making sure iv line was not taut. Triple lumen catheter slid out of it's insertion site. Four individuals noted dthat the eyelets on the catheter were severed. The sutures ans skin were both in tactinvalid data - regarding single use labeling of device. Patient medical status prior to event: critical 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4673 |
| MDR Report Key | 4673 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-01-27 |
| Date of Event | 1991-12-22 |
| Date Facility Aware | 1992-01-16 |
| Report Date | 1992-01-27 |
| Date Reported to Mfgr | 1992-01-27 |
| Date Added to Maude | 1993-06-01 |
| 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 |
| Product Code | GBP |
| Date Received | 1992-07-31 |
| ID Number | TRIPLE LUMEN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4389 |
| Manufacturer | ARROW INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |