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

Model Number 654401

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return.It has not been received.

Event 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.

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
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9184506
• MDR Text Key: 164882576
• Report Number: 9615050-2019-00431
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10887787006732
• UDI-Public: (01)10887787006732(17)220201(10)3904236
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1