MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-09-23 for UROPASS AS 13/15FR X 54 CM 5/BX 61354BX manufactured by Teleflex Medical Oem.
[160698123]
The device was not returned to the service center for evaluation. The cause of the reported event cannot be determined. The 61354bx instruction manual? Avoid contact with sharp objects as the device can be easily nicked, thereby increasing the potential for breakage.?
Patient Sequence No: 1, Text Type: N, H10
[160698124]
The service center was informed that during that an unspecified procedure, the access sheath broke during insertion. It is unknown if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-01127 |
| MDR Report Key | 9104106 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-09-23 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-08-18 |
| Date Mfgr Received | 2019-10-02 |
| Date Added to Maude | 2019-09-23 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROPASS AS 13/15FR X 54 CM 5/BX |
| Generic Name | UROPASS AS 13/15FR X 54 CM 5/BX |
| Product Code | KNY |
| Date Received | 2019-09-23 |
| Model Number | 61354BX |
| Lot Number | 09M170013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-23 |