MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-30 for HEMOCHRON TEST TUBE P-215 manufactured by Intl Technidyne Corp..
[16033103]
Test tubes found to be defective during daily calibration. Calibrations were excessively high. The mfr was notified and will replace this lot number by 10/13/95. Defective lot returned to mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007509 |
| MDR Report Key | 27592 |
| Date Received | 1995-10-30 |
| Date of Report | 1995-10-18 |
| Date of Event | 1995-10-12 |
| Date Added to Maude | 1995-11-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON TEST TUBE |
| Generic Name | TEST TUBE |
| Product Code | JBT |
| Date Received | 1995-10-30 |
| Returned To Mfg | 1995-10-13 |
| Model Number | P-215 |
| Lot Number | NESF 85 |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28509 |
| Manufacturer | INTL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 088202425 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-10-30 |