MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-20 for VACUTAINER BRAND 27X40030 27-L40029(GJ) manufactured by Becton Dickinson Vacutainer Systems And Labware.
[102786]
Glass specimen vial shattered when swab was being used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012507 |
| MDR Report Key | 133623 |
| Date Received | 1997-11-20 |
| Date of Report | 1997-11-07 |
| Date of Event | 1997-11-06 |
| Date Added to Maude | 1997-11-24 |
| 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 | VACUTAINER BRAND |
| Generic Name | ANAEROBIC SPECIMEN COLLECTION |
| Product Code | JTX |
| Date Received | 1997-11-20 |
| Model Number | 27X40030 |
| Catalog Number | 27-L40029(GJ) |
| Lot Number | REORDER # 3650 |
| ID Number | PAT NO. 3,939,044 |
| Device Expiration Date | 1998-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 130592 |
| Manufacturer | BECTON DICKINSON VACUTAINER SYSTEMS AND LABWARE |
| Manufacturer Address | 150 S. 1ST ST. BROKEN BOW NE 68822 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-20 |