MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-30 for BBL GASPAK SYSTEM manufactured by Becton Dickinson Microbiology Systems.
[17235]
On 2 recent occasions the jar has blown the lid and clamp off as the medical technologist was tightening the clamp on the jar. (proper procedure). Personnel were hit with lid and/or clamp. Both clamps broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006101 |
| MDR Report Key | 22069 |
| Date Received | 1995-05-30 |
| Date of Report | 1995-05-10 |
| Date of Event | 1995-04-18 |
| Date Added to Maude | 1995-06-01 |
| 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 | BBL GASPAK SYSTEM |
| Generic Name | GASPAK SYSTEM |
| Product Code | KZJ |
| Date Received | 1995-05-30 |
| Lot Number | 10064075006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 22158 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-05-30 |