MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-09-20 for RLV-2100 B VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..
[55170732]
The sample was attached to 48" water head height which is approximately 1. 73 psi (89. 76mmhg), it did not leak at the umbrella valve. The sample was attached to the roller pump and tested at low speed and high speed. No leak was seen. Then the sample was tested at different pressure settings of negative and positive pressures, the valve leaked at positive pressure of 1310mmhg. These valves are designed for pressure relief at a negative pressure of -200mmhg and at a positive pressure <1300mmhg. The roller pump was ran to test for retrograde flow, the valve leaked at the pressure relief band as it is designed to do so. Evaluation in progress, not yet complete.
Patient Sequence No: 1, Text Type: N, H10
[55170733]
The foreign distributor (b)(6) reported an issue encountered with the use of the cardiopulmonary suction control device from one of their customers. The report stated that the device leaked for approximately 2-3 minutes during use. The report stated the device was removed from use and a different one was used to complete the procedure. The patient was given a transfusion to address the blood loss (volume not provided) with no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for evaluation. The device is a suction control device sold in bulk non-sterile form to the distributor for additional processing prior to end-use.
Patient Sequence No: 1, Text Type: D, B5
[55801630]
No visual or functional anomalies were found with the device sample. The valve met specification. The device history record for the applicable lot of product did not show any manufacturing or quality concerns similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00047 |
| MDR Report Key | 5963860 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-09-20 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-08-22 |
| Date Mfgr Received | 2016-08-22 |
| Device Manufacturer Date | 2016-01-18 |
| Date Added to Maude | 2016-09-20 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| 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 | RLV-2100 B VACUUM RELIEF VALVE |
| Generic Name | SUCTION CONTROL VALVE |
| Product Code | DWD |
| Date Received | 2016-09-20 |
| Returned To Mfg | 2016-08-24 |
| Model Number | 4103202 |
| Lot Number | 050538 |
| Device Availability | R |
| 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 | 2016-09-20 |