MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-30 for BLOOD COLLECTION SET 2C7619 manufactured by Baxter Healthcare Corp..
[26985]
Conducting a routine therapeutic phlebotomy on pt, when the flow of blood began to slow down suddenly. Immediately checked for possible causes and found the blood collection tubing to be flattening (or collapsing). Also observed a crimped area where the clamp had been closed. Tried every technique known to get blood to flow but could not set it. Rptr was forced to restick pt in another vein to finish phlebotomy. Tubing worked on second attempt but ran very slowly. Pt has been treated at rptr's facility over 50 times before for same procedure using a different brand of tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008968 |
| MDR Report Key | 32391 |
| Date Received | 1996-04-30 |
| Date of Report | 1996-03-26 |
| Date of Event | 1996-03-26 |
| 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 | 1996-04-30 |
| Catalog Number | 2C7619 |
| Lot Number | U288100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33668 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | ROUND LAKE IL 60073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-30 |