MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-16 for MTS DISPENSER 0.5 ML MTS9610 manufactured by Micro Typing Systems, Inc..
[564166]
A customer observed that the mts 0. 5 ml dispenser did not dispense the correct volume. Incorrect dispense volume may lead to erroneous test results and the possibility of transfusion of incompatible blood. There was no report of harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[7805310]
The customer was sent a replacement and the device in question was discarded. No evaluation was performed prior to disposal. The root cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00283 |
| MDR Report Key | 785883 |
| Report Source | 05,06 |
| Date Received | 2006-11-16 |
| Date of Report | 2006-11-16 |
| Date of Event | 2005-08-22 |
| Date Mfgr Received | 2005-08-22 |
| Date Added to Maude | 2006-11-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID HAGEN, SITE MANAGER |
| Manufacturer Street | 1295 SW 29TH AVENUE |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS DISPENSER 0.5 ML |
| Generic Name | DISPENSER |
| Product Code | GJG |
| Date Received | 2006-11-16 |
| Model Number | NA |
| Catalog Number | MTS9610 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 773682 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS DISPENSER 05 ML |
| Baseline Generic Name | DISPENSER |
| Baseline Model No | NA |
| Baseline Catalog No | MTS9610 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-16 |