MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-10-28 for SENSITITRE MUELLER-HINTON BROTH W/TES NONE T3462 manufactured by Trek Diagnostic Systems.
[15610760]
In 2008, lab manager reported: "we had a little lab accident yesterday where the person was screwing on a dose head on to a mh broth tube after inoculation and the neck broke. The glass deeply cut a finger and required stitches. A tube was also broken the day before. The lot# is 148641sa. We are not implanting the craftsmanship of the tube, but just wanted to let everyone know and see if anyone else has had problems. " ten days later, the lab manager provided further detail: "the person is doing well and does not seem to have any adverse problems due to the injury (besides the cut). Around 4:00 in the afternoon is when the incident occurred and the person was working with an e. Coli 0157:h7. The person had inoculated 10 ul from the 0. 5 equivalent to the 10 ml mh tube and started screwing the dose head on, when the neck broke. The thumb was sliced open and we took the person to the occupational health clinic here. They cleaned the wound, applied 7 stitches, and gave him bactrim as a precaution. "
Patient Sequence No: 1, Text Type: D, B5
[15986384]
Reviewed complaints for similar incidents. There were no other reports to tube breakage since 2004. Reviewed batch history record. There were no processing problems or unusual tube breakage during processing. Reviewed use of the tube lot that was used in this batch of broth.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183729-2008-00001 |
| MDR Report Key | 1215489 |
| Report Source | 06 |
| Date Received | 2008-10-28 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-10-09 |
| Date Mfgr Received | 2008-10-10 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-11-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERESA ANACKER |
| Manufacturer Street | 210 BUSINESS PARK DR. |
| Manufacturer City | SUN PRAIRIE WI 53590 |
| Manufacturer Country | US |
| Manufacturer Postal | 53590 |
| Manufacturer Phone | 6088373788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSITITRE MUELLER-HINTON BROTH W/TES |
| Product Code | JTZ |
| Date Received | 2008-10-28 |
| Model Number | NONE |
| Catalog Number | T3462 |
| Lot Number | 148614SA |
| ID Number | NONE |
| Device Expiration Date | 2009-03-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TREK DIAGNOSTIC SYSTEMS |
| Manufacturer Address | SUN PRAIRIE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-28 |