MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-07-10 for RLV 2100 B VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..
[6026895]
The international distributor ((b)(4)) reported an issue encountered by their customer while using the suction control valve. This valve is sold by the manufacturer as an oem device to the distributor for further processing/sterilization. The report stated that the perfusionist observed the device leaking during the surgical procedure. There was no patient information provided. There were no actions taken during the procedure as a result of the alleged event. The was no impact to the patient as a result of the alleged event. The distributor and the customer were unsure of the lot number of the implicated product but know it was one of three possible lot numbers. None of those lots remains in the manufacturer's inventory for analysis.
Patient Sequence No: 1, Text Type: D, B5
[14212884]
Received two samples in one bag from the customer, one was assigned to cc15-169 and the other to cc15-170. It is unknown what lot number the samples are from. The sample for cc15-169 was tested on (b)(6) 2015. The sample was attached to 48" water head height which is approximately 1. 73 psi (89. 76mmhg), the sample leaked at the umbrella valve. These valves are designed for pressure relief at a negative pressure of -200mmhg and at a positive pressure <1300mmhg. To further investigate the root cause the sample was cut open to check the seating of the umbrella valve as it was evident from the amount of leak that the umbrella valve is not seated properly. After cutting the valve open, it was confirmed that the umbrella valve was curled on one side causing the valve to leak. A cpar 15--2 had already been identified and opened to address this issue for leaking valves. The device history records of lot 047578, 047470 & 047264 were reviewed; the inspection report showed that no defect was found and rejected and no specific manufacturing yield issue was reported similar to this complaint condition. Lot 047578 manufacture date: (b)(6) 2014 lot 047470 manufacture date: (b)(6) 2014 lot 047264 manufacture date: (b)(6) 2014
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2015-00048 |
| MDR Report Key | 4906307 |
| Report Source | 01,08 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-16 |
| Date Added to Maude | 2015-07-13 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RLV 2100 B VACUUM RELIEF VALVE |
| Generic Name | CPBP SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2015-07-10 |
| Returned To Mfg | 2015-06-19 |
| Model Number | 4103202 |
| Operator | OTHER |
| Device Availability | R |
| 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 | 2015-07-10 |