MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-17 for BAC-T-ALERT manufactured by Organon Teknika Corp..
[22667]
Rptr was trying to extract a blood culture bottle from the device when the bottle broke causing a laceration to the right thumb. Rptr went to the er for treatment and received stitches and a tetanus shot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008882 |
| MDR Report Key | 32045 |
| Date Received | 1996-04-17 |
| Date of Report | 1996-04-03 |
| Date of Event | 1996-03-28 |
| Date Added to Maude | 1996-04-19 |
| 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 | BAC-T-ALERT |
| Generic Name | CONTINUOUS MONITORING BLOOD CULTURE |
| Product Code | JSC |
| Date Received | 1996-04-17 |
| Lot Number | 203568 |
| ID Number | 155841 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33286 |
| Manufacturer | ORGANON TEKNIKA CORP. |
| Manufacturer Address | 5300 S PORTLAND AVE OKLAHOMA CITY OK 73119 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-17 |