MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 11-IN EXTENSION SET W/ MAX Y AND; INTRAVASCULAR ADMINISTRATION SET

Model Number	MPX5304-C
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 11-in extension set w/ max y and disconnected and there was blood backflow.The following information was provided by the initial reporter: material no: mpx5304-c batch no: 20036111.It was reported that tubing disconnected in a joined area and patient was bleeding from what was left of t-connector.Event description per email states: t-connector attached to iv was defective.The tubing disconnected in a joined area and the pt rang because he was bleeding from what was left of t-connector.Minimal blood loss and a new intact t connector attached.
Additional Manufacturer Narrative
Investigation: a device history record review for model mpx5304-c lot number 20036111 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of connection issues with lot #20036111 regarding item #mpx5304-c.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that 11-in extension set w/ max y and disconnected and there was blood backflow.The following information was provided by the initial reporter: material no: mpx5304-c batch no: 20036111 it was reported that tubing disconnected in a joined area and patient was bleeding from what was left of t-connector.Event description per email states: t-connector attached to iv was defective.The tubing disconnected in a joined area and the pt rang because he was bleeding from what was left of t-connector.Minimal blood loss and a new intact t connector attached.

• Brand Name: 11-IN EXTENSION SET W/ MAX Y AND
• 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: 10694555
• Report Number: 9616066-2020-20093
• Device Sequence Number: 3486363
• Product Code: FPA
• UDI-Device Identifier: 50885403237247
• UDI-Public: 50885403237247
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/22/2020

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: 03/13/2025
• Device Model Number: MPX5304-C
• Device Catalogue Number: MPX5304-C
• Device Lot Number: 20036111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/17/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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
• Patient Age: 63 YR