MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-15 for SYRINGE, EPIDURAL A COMPONENT IN BAXTER SPINAL ANESTHESIA TRAY manufactured by Becton Dickinson.
[236400]
While placing an epidural catheter pre-op for a continuous epidural, part of the b-d epidural glass syringe (the top of the plunger) shattered under the "mda's" thumb. The "mda" was injecting a 5cc test dose through the epidural catheter. The syringe had only been used for compressing air with the loss of resistance technique for placing the epidural needle previously. Only the part of the syringe designed for thumb pressure shattered (into many pieces). There was no excessive or unusual pressure used. The syringe was a component in the baxter spinal anesthesia tray #2t0661, lot no. Gd722603, exp 8/8/2001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020822 |
| MDR Report Key | 312704 |
| Date Received | 2001-01-15 |
| Date of Report | 2001-01-12 |
| Date of Event | 2001-01-03 |
| Date Added to Maude | 2001-01-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SYRINGE, EPIDURAL |
| Generic Name | EPIDURAL SYRINGE |
| Product Code | FME |
| Date Received | 2001-01-15 |
| Model Number | A COMPONENT IN BAXTER |
| Catalog Number | SPINAL ANESTHESIA TRAY |
| Lot Number | TRAY-GD722603 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 302464 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DR MAIL CODE 233 FRANKLIN LAKES NH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-01-15 |