MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-29 for BLOOD COLLECTION SET 2C7619 manufactured by Baxter Healthcare Corp..
[19659]
Inserted an 18g catheter into left basilic vein. Procedure took 35 mins. Flow was sluggish and tubing collapsed. Had to manipulate tubing; therefore, iv was manipulated causing pt great discomfort. Iv clotted before treatment was completed. Had to restick pt. On last admission 3/16/96 an 18 gauge angiocath inserted into the same vein without difficulty. Obtained 500ml's of blood in 12 mins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008969 |
| MDR Report Key | 32392 |
| Date Received | 1996-04-29 |
| Date of Report | 1996-03-30 |
| Date of Event | 1996-03-30 |
| Date Added to Maude | 1996-05-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOD COLLECTION SET |
| Generic Name | BLOOD COLLECTION SET |
| Product Code | KST |
| Date Received | 1996-04-29 |
| Catalog Number | 2C7619 |
| Lot Number | U 288100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33669 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | ROUND LAKE IL 60073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-29 |