MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 10/12FR X 46 CM 5/BX; ACCESS SHEATH

Model Number	61046BX
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that user found a foreign object inside the sterile package before its use.No patient harm or injury occurred due to this malfunction.
Additional Manufacturer Narrative
The device was returned to olympus.The evaluation has not yet taken place and the investigation is on going.However, an image was provided by the customer confirming the existence of a foreign material inside the packaging.If additional information becomes available, a supplemental report will be filed.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.An examination of the package revealed there was a loose piece that appeared to be the same color and material of the dilator clip at the proximal end of the device and was located near the distal tip of the device.The device was inspected for damage while still inside the sterile barrier and there were no signs of damage.It was confirmed that a loose piece was in the package.It was likely the same material as the dilator clip.There was no indication that during the assembly process that a part broke off causing the foreign material inside the pouch.

• Brand Name: UROPASS AS 10/12FR X 46 CM 5/BX
• Common Device Name: ACCESS SHEATH
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane n, ste 160; plymouth MN 55447
• MDR Report Key: 12094870
• Report Number: 8010047-2021-08212
• Device Sequence Number: 4187271
• Product Code: KNY
• UDI-Device Identifier: 00821925035331
• UDI-Public: 00821925035331
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 61046BX
• Device Lot Number: 09C2000017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1