MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for UROPASS AS 13/15FR X 46 CM 5/BX 61346BX manufactured by Teleflex Medical Oem.
[112568613]
The referenced packaging and device was not returned to olympus. The exact cause of the reported event could not be determined at this time. However, if the device is returned at a later, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[112568614]
Olympus was informed that prior to procedure the sterile packaging of the device was found compromised as a hair strand was discovered inside the packaging. The hair strand was observed in the package after being opened. In addition, the packaging was inspected upon receipt with no damages and was stored on a shelf. The device was not used. The package and device will be returned to olympus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00368 |
| MDR Report Key | 7631468 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2018-06-22 |
| 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 | 0 |
| Brand Name | UROPASS AS 13/15FR X 46 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-07-09 |
| Model Number | 61346BX |
| Catalog Number | 61346BX |
| Lot Number | 09B1800257 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-22 |