MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LTXFR CYSTOSCOPY IRR; ADMINISTRATION SET

Model Number	654401
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return.It has not been received.
Event or Problem Description
The event occurred on an unknown date and involved a latex free cystoscopy irrigation set that was reported to have a hair inside of the tubing noted while still in the packaging.There was no patient involved.
Additional Manufacturer Narrative
No list #065440403 product samples or videos were returned for investigation.An image was returned which shows a hair on the set, it is not clear from the image whether the hair was inside of the package, on the tubing, or within the tubing (in the fluid path).The reported complaint can be confirmed, the probable cause is due to a gowning error at the manufacturing site.The lot history was reviewed and there were no nonconformance's found that would have contributed to the reported complaint.

• Brand Name: LTXFR CYSTOSCOPY IRR
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9184506
• Report Number: 9615050-2019-00431
• Device Sequence Number: 2402354
• Product Code: GBX
• UDI-Device Identifier: 10887787006732
• UDI-Public: (01)10887787006732(17)220201(10)3904236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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 Expiration Date: 02/01/2022
• Device Model Number: 654401
• Device Catalogue Number: 065440403
• Device Lot Number: 3904236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1