MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-30 for RETROGUARD ARTERIAL SAFETY VALVE PLEGIAGUARD CARDIOPLEGIA S 4007100 * manufactured by Quest Medical, Inc..
[17493063]
The customer reported that during a procedure, when getting ready to come off bypass the "tubing became disconnected from the valve. " no samples were saved. Product code 4007100; lot number 27182. L13.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00147 |
| MDR Report Key | 794199 |
| Report Source | 05,06 |
| Date Received | 2006-11-30 |
| Date of Report | 2006-11-29 |
| Date of Event | 2006-11-13 |
| Date Mfgr Received | 2006-11-16 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2006-12-15 |
| 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 PLEGIAGUARD CARDIOPLEGIA S |
| Generic Name | CPBP ADAPTER, STOPCOCK, MANIFOLD OR FITTING |
| Product Code | MJJ |
| Date Received | 2006-11-30 |
| Model Number | 4007100 |
| Catalog Number | * |
| Lot Number | 27182.L13 |
| ID Number | * |
| Device Expiration Date | 2009-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781820 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | RETROGUARD (STERILE) |
| Baseline Generic Name | RETROGUARD |
| Baseline Model No | 4007100 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K922356 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-30 |