MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-07 for MULTIPLE LUMEN ACCESS PRODUCTS M3L9FHKI * manufactured by Baxter Healthcare Corporation Cardiovascular Group.
[161844]
Angiocath inserted via right internal jugular. Syringe attached and blood drawn for lab test. M. D. Removed needle. J shaped guidewire threaded without difficulty. Catheter removed over needle. It was noted that sheath was not attached to hub. Site explored. X-rays negative for foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 254789 |
| MDR Report Key | 254789 |
| Date Received | 1999-12-07 |
| Date of Report | 1999-11-21 |
| Date of Event | 1999-11-09 |
| Date Facility Aware | 1999-11-09 |
| Report Date | 1999-11-21 |
| Date Reported to Mfgr | 1999-11-21 |
| Date Added to Maude | 1999-12-21 |
| 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 | 0 |
| 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 | MULTIPLE LUMEN ACCESS PRODUCTS |
| Generic Name | AVA CATHETER |
| Product Code | JCY |
| Date Received | 1999-12-07 |
| Model Number | M3L9FHKI |
| Catalog Number | * |
| Lot Number | 949G0983 |
| ID Number | * |
| Device Expiration Date | 2001-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 246719 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION CARDIOVASCULAR GROUP |
| Manufacturer Address | 1402 EAST ALTON IRVINE CA 92614 US |
| Baseline Brand Name | ADVANCED VENOUS ACCESS (AVA) CATHETER |
| Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Baseline Model No | M3L9FHKI |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981909 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-12-07 |