MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-12-03 for PLUNGER HOLDER/ TRACK II PLUNGER HOLDER/TRACK II NA manufactured by Medex, Inc..
[357668]
During in-house testing, the u-spring was found damaged in such as way, the plunger holder/track ii 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 | 1036813-2003-00090 |
| MDR Report Key | 501229 |
| Report Source | 07 |
| Date Received | 2003-12-03 |
| Date of Report | 2003-11-03 |
| Date of Event | 2003-11-03 |
| Date Mfgr Received | 2003-11-03 |
| Date Added to Maude | 2003-12-17 |
| 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 ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | MEDEX |
| Manufacturer Street | 4350 RIVER GREEN PARWAY SUITE 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 | 2003-12-03 |
| 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 | 490000 |
| Manufacturer | MEDEX, INC. |
| 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 | 2003-12-03 |