MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-05-23 for RETROGUARD ARTERIAL SAFETY VALVE 4007200 manufactured by Quest Medical, Inc.
[109111229]
The valve is sold bulk, non-sterile to the customer for further processing into final sterile packs. Device evaluation could not be conducted as the complaint sample was not returned. A dhr review was conducted and showed no manufacturing anomalies related to the reported complaint condition. The root cause of the alleged issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
[109111230]
A report received from a customer states that the valve leaked during use and had to be cut from the circuit. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132403451]
The complaint sample was not returned for investigation. 10units of devices from another lot were evaluated. To demonstrate the scenario, the devices were connected to a rotary pump and subjected to a forward flow of 1. 0 l/min. During the process, a hemostat was used to replicate the crack by subjecting the valve to blunt force until the air bubbles disappear. 3 out of the 10 valves generated the crack similar to the one seen in the picture sent by the customer. Subjecting the valve to blunt force can cause cracks to generate on the weld line. As a proactive measure, the melt temperature for the valves molding process will be increased to 517? F to minimize any cracks developing from application of hemostats by users.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00046 |
| MDR Report Key | 7538970 |
| Report Source | OTHER |
| Date Received | 2018-05-23 |
| Date of Report | 2018-08-17 |
| Date Mfgr Received | 2018-05-10 |
| Date Added to Maude | 2018-05-23 |
| 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 | 3 |
| Manufacturer Contact | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETROGUARD ARTERIAL SAFETY VALVE |
| Generic Name | CPB CHECK VALVE |
| Product Code | MJJ |
| Date Received | 2018-05-23 |
| Model Number | 4007200 |
| Catalog Number | 4007200 |
| Lot Number | 054709 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-23 |