MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-27 for ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT AK-15703-A manufactured by Arrow International, Inc..
[3358]
While inserting a triple lumen catheter - after the catheter was in place; the physician was pulling out the guide wire and noted central wire was broken, the outter wire was coming through, after about 3 inches from cold wire the distal piece came through the cather, the intere wire was retrivedinvalid 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. 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: component failure, telemetry failure, none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device recalled by manufacturer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5919 |
| MDR Report Key | 5919 |
| Date Received | 1993-03-27 |
| Date of Report | 1993-03-03 |
| Date of Event | 1993-02-28 |
| Date Facility Aware | 1993-02-28 |
| Report Date | 1993-03-03 |
| Date Reported to FDA | 1993-03-03 |
| Date Reported to Mfgr | 1993-03-01 |
| Date Added to Maude | 1993-07-29 |
| 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 | ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT |
| Generic Name | MULTI LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 1993-03-27 |
| Model Number | AK-15703-A |
| Lot Number | AK-1-335-2 |
| ID Number | 00899380 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5617 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-03-27 |