MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-26 for MULTI-LUMEN CVC KIT AK-45703-BC UNKNOWN manufactured by Arrow International, Inc..
[15033900]
Patient here with gunshot wound. Patient with swan catheter, air noted in cordis, vital signs stable, no decrease in oxygen saturation. Arrow multi-lumen cvc catheter, defective cordis and or diaphragm on cordis. After performing other procedure on the patient, physician noted air in cordis lumen despite iv, intervenous, fluid/medications in all lines. Patient on positive pressure ventilation and appeared that cordis was sucking air. Line emergently changed per physician. Vital sign monitoring - remained stable with no decrease in oxygen saturation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 549807 |
| MDR Report Key | 549807 |
| Date Received | 2004-08-26 |
| Date of Report | 2004-08-26 |
| Date of Event | 2004-07-06 |
| Report Date | 2004-08-26 |
| Date Reported to FDA | 2004-08-26 |
| Date Added to Maude | 2004-10-21 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 CVC KIT |
| Generic Name | MULTI-LUMEN CVC |
| Product Code | GBP |
| Date Received | 2004-08-26 |
| Model Number | AK-45703-BC |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | Y |
| Device Sequence No | 1 |
| Device Event Key | 539323 |
| Manufacturer | ARROW INTERNATIONAL, INC. |
| Manufacturer Address | 2400 BERNVILLE ROAD READING PA 19605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-08-26 |