MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-30 for MULTI LUMEN CATHETER WITH ANTISEPTIC SURFACE AK 22 703 manufactured by Arrow Internationa, Hill & Georges Avenues, Reading, Pa.
[2058]
Triple lumen catheter was inserted on 3/23/92. On 3/26/92 catheter was leaking beneath the skin. Catheter was removed on 3/26/92 and on visual exam was found to have a crack at the 12-13 cm markdevice 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. Invalid data - regarding evaluation by user after event. Method of evaluation: actual device involved in incident was evaluated, invalid data. Results of evaluation: inadequate quality assurance, port. Conclusion: device failure directly caused event, device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: invalid data. 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 | 3087 |
| MDR Report Key | 3087 |
| Date Received | 1992-07-30 |
| Date of Report | 1992-04-02 |
| Date of Event | 1992-03-23 |
| Date Facility Aware | 1992-03-26 |
| Report Date | 1992-04-02 |
| Date Reported to Mfgr | 1992-04-02 |
| Date Added to Maude | 1993-04-06 |
| 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 | MULTI LUMEN CATHETER WITH ANTISEPTIC SURFACE |
| Product Code | GBP |
| Date Received | 1992-07-30 |
| Catalog Number | AK 22 703 |
| Lot Number | AK-2-336-1 |
| Device Expiration Date | 1993-12-01 |
| Device Availability | Y |
| Device Age | 01-MAR-92 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 2888 |
| Manufacturer | ARROW INTERNATIONA, HILL & GEORGES AVENUES, READING, PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-30 |