MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV T-CONN W/LUER SLIP ADPT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20051E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that t-conn w/luer slip adpt tubing was damaged.The following information was provided by the initial reporter: the reported feedback suggests smartsite tubing torn into two.Smartsite 20051e was torn into two pieces when distributor stretching the tubing by hand to show its strength and flexibility.
Additional Manufacturer Narrative
One 20051e sample was received for investigation; the product appeared unused with no signs of residual fluid.No packaging was received with the sample, however the customer indicates the affected lot number to be 20016797.A section of an unknown set was received connected to the female luer of the returned sample.A visual inspection confirmed the customer's experience as the tubing was identified to have been torn approximately 10mm from the female luer component.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot: 20016797 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance the tubing of the product appeared to have been torn; as the customer confirmed the damage occurred during attempts to stretch the product, it is unlikely that the damage occurred as a result of a manufacturing defect.A review of the customer feedback database indicates that this is an isolated occurrence with no other report for damage of this nature against the 20051e set in the past 12 months.
Event or Problem Description
It was reported that t-conn w / luer slip adpt tubing was damaged.The following information was provided by the initial reporter: the reported feedback suggests smartsite tubing torn into two.Smartsite 20051e was torn into two pieces when distributor stretching the tubing by hand to show its strength and flexibility.

• Brand Name: T-CONN W/LUER SLIP ADPT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10315973
• Report Number: 9616066-2020-02108
• Device Sequence Number: 11394417
• Product Code: FPA
• UDI-Device Identifier: 07613203012331
• UDI-Public: 07613203012331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: Other
• Device Expiration Date: 01/22/2023
• Device Model Number: 20051E
• Device Catalogue Number: 20051E
• Device Lot Number: 20016797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: 20200629; 20200629
• Outcome Attributed to Adverse Event: Other