MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for URINRY DRN BG W/ANTI REFL 390060 manufactured by Teleflex Medical.
[45481407]
(b)(4). The device samples have been returned but the investigation report has not been submitted at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[45481408]
Reported event: the bags would not allow urine to flow in through the anti-reflux device. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[45487734]
(b)(4). Result of investigation: (root cause) the returned sample was tested and performed as designed. There is no factory history of issues with this lot or model number. It is always possible that the pvc nrv was folded in the package and did not open to allow the urine to enter the bag. Corrective and preventative action taken: none
Patient Sequence No: 1, Text Type: N, H10
[45487735]
Reported event: the bags would not allow urine to flow in through the anti-reflux device. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00094 |
| MDR Report Key | 5643924 |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-05-17 |
| Date Added to Maude | 2016-05-10 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINRY DRN BG W/ANTI REFL |
| Product Code | FAQ |
| Date Received | 2016-05-10 |
| Returned To Mfg | 2016-04-21 |
| Catalog Number | 390060 |
| Lot Number | 20141225 |
| Device Expiration Date | 2019-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-10 |