MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-24 for PRO-VENT PLUS ABG KIT 4695 manufactured by Sims.
[22517]
Performed abg on pt, removed needle and capped syringe with filter. Proceeded to remove air bubble by pressing plunger when blood squirted directly into face and into left eye. After incident, found small hole in syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009563 |
| MDR Report Key | 34432 |
| Date Received | 1996-07-24 |
| Date of Report | 1996-07-15 |
| Date of Event | 1996-07-12 |
| Date Added to Maude | 1996-07-26 |
| 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 | PRO-VENT PLUS ABG KIT |
| Generic Name | ARTERIAL BLOOD GAS KIT |
| Product Code | LBT |
| Date Received | 1996-07-24 |
| Returned To Mfg | 1996-07-15 |
| Catalog Number | 4695 |
| Lot Number | 605441 |
| Device Expiration Date | 1999-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35790 |
| Manufacturer | SIMS |
| Manufacturer Address | 15 KIT ST KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-07-24 |