MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 8-IN PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX5301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the 8-in pressure rated extension set disconnected at the y-site when the patient turned in bed.The following information was provided by the initial reporter: customer has had two extension sets in the past week disconnect at the y-site with a patient turning in the bed.The extension set in the pictures was easily pulled off without great effort.
Additional Manufacturer Narrative
H.6.Investigation: a sample has been received and analyzed by our quality team.The customer's complaint of separation has been verified.A device history record review for model mx5301 lot number 20065502 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.After close analyses under microscope, the root cause of the separation is an insufficient/ uneven application of solvent at tubing fitment.
Event or Problem Description
It was reported that the 8-in pressure rated extension set disconnected at the y-site when the patient turned in bed.The following information was provided by the initial reporter: customer has had two extension sets in the past week disconnect at the y-site with a patient turning in the bed.The extension set in the pictures was easily pulled off without great effort.

• Brand Name: 8-IN PRESSURE RATED EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10766668
• Report Number: 9616066-2020-20217
• Device Sequence Number: 11047513
• Product Code: FPA
• UDI-Device Identifier: 50885403237551
• UDI-Public: 50885403237551
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 06/17/2025
• Device Model Number: MX5301
• Device Catalogue Number: MX5301
• Device Lot Number: 20065502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1