MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-06-04 for ADVANCED VENOUS ACCESS CATHETER M3L9FHK NA manufactured by Baxter Healthcare Corp..
[128771]
It was reported that a pt was admitted with severe septic shock. It was stated that the catheter was inserted and resistance was noted. Fluid was infused through the line. An x-ray was taken and the catheter was repositioned. It was reported that a pneumothorax occurred; the pt coded and expired. Followup with the physician indicated that the report is not attributed to the catheter per se, however more secondary to the pt's subcutaneous condition. No autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-1999-00166 |
| MDR Report Key | 226048 |
| Report Source | 05,06,07 |
| Date Received | 1999-06-04 |
| Date of Report | 1999-06-03 |
| Date of Event | 1999-05-07 |
| Date Facility Aware | 1999-05-07 |
| Date Mfgr Received | 1999-05-07 |
| Date Added to Maude | 1999-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED VENOUS ACCESS CATHETER |
| Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Product Code | JCY |
| Date Received | 1999-06-04 |
| Model Number | M3L9FHK |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 219207 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 17221 RED HILL AVENUE IRVINE CA 92614 US |
| Baseline Brand Name | ADVANCED VENOUS ACCESS CATHETER |
| Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Baseline Model No | M3L9FHK |
| 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 | 1. Death | 1999-06-04 |