MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-01-21 for RLV 2100 "B" SUCTION CONTROL DEVICE 4103102 manufactured by Quest Medical, Inc..
[36492263]
The reported complaint condition could not be confirmed. The sample (lot unknown) was attached to a roller pump and ran at both low and high speeds. No leaks were observed. The testing was repeated at various pressures as well. The device continued to perform as expected.
Patient Sequence No: 1, Text Type: N, H10
[36492264]
The international distributor ((b)(4)) reported an issue encountered with the suction control device during use. They stated their customer reported that during a procedure in (b)(6) 2015, when blood flowed through the pressure relief valve case, blood was observed to be leaking from it. They said approximately 10 mls of blood leaked before it was noticed. It was replaced by another valve and the procedure resumed with no danger to patient. The device lot number was not recorded or provided. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2015-00121 |
| MDR Report Key | 5382692 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-01-21 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-11-20 |
| Date Added to Maude | 2016-01-21 |
| 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" SUCTION CONTROL DEVICE |
| Generic Name | CARDIOVASCULAR SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2015-12-01 |
| Model Number | 4103102 |
| 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 | 2016-01-21 |