MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-08-15 for BBL LIM BROTH 296266 manufactured by Becton Dickinson.
[21594095]
The product may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate group b streptococci.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2003-00002 |
| MDR Report Key | 478937 |
| Report Source | 05 |
| Date Received | 2003-08-15 |
| Date of Report | 2003-08-15 |
| Date of Event | 2003-07-02 |
| Date Mfgr Received | 2003-07-02 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2003-08-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL LIM BROTH |
| Generic Name | CULTURE MEDIA |
| Product Code | JSD |
| Date Received | 2003-08-15 |
| Returned To Mfg | 2003-07-14 |
| Model Number | NA |
| Catalog Number | 296266 |
| Lot Number | 3129508 |
| ID Number | * |
| Device Expiration Date | 2004-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 467750 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 211520999 US |
| Baseline Brand Name | BBL LIM BROTH |
| Baseline Catalog No | 296266 |
| Baseline Device Family | BBL PREPARED TUBED AND MYCOFLASK MEDIA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 9 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833759 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-15 |