MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-26 for UROPASS AS 10/12FR X 24 CM 5/BX 61024BX manufactured by Teleflex Medical Oem.
[177765065]
The device has not been returned to the service center for evaluation of the reported event. Therefore, the exact cause of the event cannot be determined at this time. If the device becomes available, an evaluation report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177765066]
The service center received a report, medwatch (mw5091479) received on december 20, 2019, that an access sheath failed out of the box during preparation for a procedure. The uropass sheath (61024bx) was passed to the back table to a fellow and wetted prior to insertion for a cystoscopy and ureteroscopy procedure. During the preparation and inspection, the fellow observed the sheath began to chip and the tip of the sheath (61024bx) fell off. The tip and the chipped items were removed from the back table and placed back into the original packaging. It was reported the item was not expired. It was not reported if the intended procedure was continued with a new device or completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-01235 |
| MDR Report Key | 9521555 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-26 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-01-24 |
| Date Added to Maude | 2019-12-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 10/12FR X 24 CM 5/BX |
| Generic Name | URETERAL ACCESS SHEATH |
| Product Code | FGF |
| Date Received | 2019-12-26 |
| Returned To Mfg | 2020-02-18 |
| Model Number | 61024BX |
| Lot Number | 09A1700256 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-12-26 |