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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on 19 october, 2020.Medwatch report # 2700040000-2020-8065.Report source other: medwatch report.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage from the t connector could not be verified due to the product not being returned for failure investigation.A device history record review for model#: mpx5304-c lot number 20036111 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13mar2020.There were 2 quality notifications issued for the lot and material number reported by the customer during the production build of this set.One of the notifications was unrelated to the failure mode, and the other cannot be confirmed without a failure investigation.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.Root cause description: the root cause of this failure could not be identified without a failure investigation.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.
Event or Problem Description
It was reported that 11-in extension set w/ max y and leaked.The following information was provided by the initial reporter: material no.: mpx5304-c; batch no.: 20036111.It was reported there was a leak from the t connector.Verbatim: iv tubing leak from the t connector.It is possible some propofol leaked from patient's iv line causing loose iv dressing.This was reported during hand off from rn to pacu rn.No harm to patient.
Event or Problem Description
It was reported that 11-in extension set w/ max y and leaked.The following information was provided by the initial reporter: material no.: mpx5304-c batch no.: 20036111.It was reported there was a leak from the t connector.Verbatim: iv tubing leak from the t connector.It is possible some propofol leaked from patient's iv line causing loose iv dressing.This was reported during hand off from rn to pacu rn.No harm to patient.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of leakage from the t connector could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review for model mpx5304-c lot number 20036111 was performed.There were 2 quality notifications issued for the lot and material number reported by the customer during the production build of this set.One of the notifications was unrelated to the failure mode and the other cannot be confirmed without a failure investigation.

• 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: 10830684
• Report Number: 9616066-2020-20320
• Device Sequence Number: 3046074
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 10/19/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR