MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-03 for ARROW-HOWES MULTILUMEN CENTRAL VENOUS CATHETERIZATION KIT AK-25703 manufactured by Arrow.
[1003]
Spring wire guide difficult to advance. Resistence met while extricating wire. After some careful tugging, wire came out with uncoiling of peripheral wire wrap from central core wire. To all observors, the wire seemed in i piece. The re. Was contracted & stated this is a designed feature to enhance integretity of guide wire (rep. Barry howard). The device was still removed from service per physician requestinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding 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 evaluated after the event. Method of evaluation: visual examination. Results of evaluation: invalid data. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3571 |
| MDR Report Key | 3571 |
| Date Received | 1992-08-03 |
| Date of Report | 1992-06-03 |
| Date of Event | 1992-05-29 |
| Date Facility Aware | 1992-05-29 |
| Report Date | 1992-06-03 |
| Date Reported to Mfgr | 1992-05-29 |
| Date Added to Maude | 1993-04-23 |
| 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 MULTILUMEN CENTRAL VENOUS CATHETERIZATION KIT |
| Generic Name | TRIPLE LUMEN CATHETER 7FR. 3 LUMEN 20CM .035 5W6 |
| Product Code | GBP |
| Date Received | 1992-08-03 |
| Model Number | AK-25703 |
| Lot Number | AK-2-140-2 |
| Device Expiration Date | 1994-04-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 3312 |
| Manufacturer | ARROW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-08-03 |