MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-27 for BD BBL? THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1, AND HEMIN 221788 manufactured by Becton, Dickinson & Co..
[155850089]
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[155850090]
Customer reported that the bd bbl? Thioglycollate medium had non-viable organisms (long thin gram negative rods) seen in the gram stains of patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1111096-2019-00115 |
| MDR Report Key | 8935699 |
| Date Received | 2019-08-27 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-08-15 |
| Device Manufacturer Date | 2019-05-30 |
| Date Added to Maude | 2019-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 250 SCHILLING CIRCLE |
| Manufacturer City | COCKEYSVILLE MD 21030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD BBL? THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1, AND HEMIN |
| Generic Name | MULTIPURPOSE CULTURE MEDIUM |
| Product Code | JSG |
| Date Received | 2019-08-27 |
| Catalog Number | 221788 |
| Lot Number | 9150847 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 250 SCHILLING CIRCLE COCKEYSVILLE MD 21030 US 21030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-27 |