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 Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of the set separating and leaking 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 377320 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 came apart and the patient bled from it.The following information was provided by the initial reporter: material no.: 10016072 batch no.: unknown.It was reported the item came apart in the or which resulted in bleeding of a peds patient.

• 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: 10320154
• Report Number: 9616066-2020-02245
• Device Sequence Number: 3083922
• 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 a Product Problem Report?: Yes
• Operator of Device: Other
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8100, 8015, (B)(6) 2020
• Outcome Attributed to Adverse Event: Other