MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV EXT SET 3W-STCK STD HI FLOW 1SS; SET, EXTENSION, INTRAVASCULAR

Model Number	10016072
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of kinks in the tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 10016072 because a lot number was not provided by the customer.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that ext set 3w-stck std hi flow 1ss tubing kinked.The following information was provided by the initial reporter: material no.: 10016072 batch no.: unknown.It was reported that the line loops around and kinks at the loop.The other issue with this set is still a problem.The line goes in the arm (on an armboard) and then loops around and come back to the head and the anesthesiologist.The line has kinked at the loop which is an issue.The arm can be under a drape so when it has kinked, the anesthesiologist may not see.That line becomes useless once kinked.This happens regularly.

• Brand Name: EXT SET 3W-STCK STD HI FLOW 1SS
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10320198
• Report Number: 9616066-2020-02246
• Device Sequence Number: 2979003
• Product Code: FPA
• UDI-Device Identifier: 10885403234071
• UDI-Public: 10885403234071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 10016072
• Device Catalogue Number: 10016072
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other