MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-01-13 for SENSITITRE MUELLER-HINTON BROTH W/TES T3462 manufactured by Trek Diagnostic Systems, Inc..
[17486048]
In 2004, the lab tech called to report they were having problem with breaking tubes of t3462 mueller-hinton broth w/tes (mhb) in use with the v3010 sensititre autoinculator. Five days earlier, a tube inoculated with salmonella (newport) broke as user was unscrewing the dosehead from the tube after removing it from the autoinoculator. The tube broke approx. 2 cm from the top and user sustained a cut to thumb about 16 mm long and 2 mm deep. As a precautionary measure and a requirement of facility, user was checked out by an infectious disease specialist who prescribed ciprofloxacin. User did not get stitches. User could have got stitches but opted not to.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183729-2005-00001 |
| MDR Report Key | 569508 |
| Report Source | 06 |
| Date Received | 2005-01-13 |
| Date of Report | 2005-01-11 |
| Date of Event | 2004-12-09 |
| Date Mfgr Received | 2004-12-14 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-02-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERESA ANACKER |
| Manufacturer Street | 210 BUSINESS PARK DRIVE |
| Manufacturer City | SUN PRAIRIE WI 53590 |
| Manufacturer Country | US |
| Manufacturer Postal | 53590 |
| Manufacturer Phone | 6088373788 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSITITRE MUELLER-HINTON BROTH W/TES |
| Generic Name | IN VITRO DIAGNOSTIC CULTURE MEDIA |
| Product Code | JTZ |
| Date Received | 2005-01-13 |
| Model Number | NA |
| Catalog Number | T3462 |
| Lot Number | 143168SA |
| ID Number | NA |
| Device Expiration Date | 2005-01-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 559360 |
| Manufacturer | TREK DIAGNOSTIC SYSTEMS, INC. |
| Manufacturer Address | 210 BUSINESS PARK DR. SUN PRAIRIE WI 53590 US |
| Baseline Brand Name | SENSITITRE MUELLER-HINTON BROTH W/TES |
| Baseline Generic Name | IN VITRO DIAGNOSTIC CULTURE MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | T3462 |
| Baseline ID | NA |
| Baseline Device Family | SENSITITRE SUSCEPTIBILITY TEST SYSTEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K802957 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-13 |