MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-24 for BD BBL? THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1, AND HEMIN 221788 manufactured by Becton Dickinson And Co..
[164819791]
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
[164819792]
It was reported that while using bd bbl? Thioglycollate medium, enriched with vitamin k1, and hemin to grind tissue samples gram-negative rods (gnr) were observed on gram stain, with no growth on culture. Several results were reported in error, then later corrected. Customer states several patients antibiotics were changed and the hospital stay of one patient was extended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1111096-2019-00118 |
| MDR Report Key | 9112273 |
| Date Received | 2019-09-24 |
| Date of Report | 2019-09-11 |
| Date of Event | 2019-08-30 |
| Date Mfgr Received | 2019-08-30 |
| Device Manufacturer Date | 2019-05-30 |
| Date Added to Maude | 2019-09-24 |
| 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 AND CO. |
| Manufacturer Street | 2801 INDUSTRIAL DRIVE |
| Manufacturer City | MADISON WI 53713 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53713 |
| 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 | 2019-09-24 |
| 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 AND CO. |
| Manufacturer Address | 2801 INDUSTRIAL DRIVE MADISON WI 53713 US 53713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-24 |