MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-06-10 for PLUNGER HOLDER/TRACK II NA manufactured by Medex.
[17020491]
During medex' in-house testing, the hex value was not greater than co on the plunger holder, which would have caused the syringe pump to fail to alert "load syringe plunger" or "occlusion" depending on the pump's software.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036813-2004-00033 |
| MDR Report Key | 594047 |
| Report Source | 07 |
| Date Received | 2004-06-10 |
| Date of Report | 2004-05-13 |
| Date of Event | 2004-05-13 |
| Date Mfgr Received | 2004-05-13 |
| Date Added to Maude | 2005-04-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRI DAVIS |
| Manufacturer Street | 6250 SHIER-RINGS RD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | MEDEX |
| Manufacturer Street | 4350 RIVER GREEN PKY, STE 200 |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30096 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUNGER HOLDER/TRACK II |
| Generic Name | PLUNGER HOLDER/TRACK II |
| Product Code | FIH |
| Date Received | 2004-06-10 |
| Model Number | PLUNGER HOLDER/TRACK II |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 583874 |
| Manufacturer | MEDEX |
| Manufacturer Address | 4350 RIVER GREEN PKWY. SUITE 200 DULUTH GA 30096 US |
| Baseline Brand Name | PLUNGER HOLDER/TRACK II |
| Baseline Generic Name | PLUNGER HOLDER/TRACK II |
| Baseline Model No | PLUNGER HOLDER/ |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SYRINGE INFUSION PUMP COMPONENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-10 |