MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-07-21 for RETROGUARD ARTERIAL SAFETY VALVE 4007200 * manufactured by Quest Medical, Inc..
[478454]
The customer reported that during incoming inspection, during further manufacturing and on the field, they have found cracks on the housing of the device. Samples were saved and will be returned to quest. Product code 4007200, lot numbers 25304 & 25595.
Patient Sequence No: 1, Text Type: D, B5
[7786436]
Add'l lot # 25595.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2006-00060 |
| MDR Report Key | 742071 |
| Report Source | 00 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-21 |
| Date Mfgr Received | 2006-06-27 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-08-01 |
| 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 | MEGAN SIMS |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETROGUARD ARTERIAL SAFETY VALVE |
| Generic Name | FLOW CHECK VALVE |
| Product Code | MJJ |
| Date Received | 2006-07-21 |
| Returned To Mfg | 2006-07-10 |
| Model Number | 4007200 |
| Catalog Number | * |
| Lot Number | 25304 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 729910 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | RETROGUARD |
| Baseline Generic Name | FLOW CHECK VALVE |
| Baseline Model No | 4007200 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-21 |