MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 8.5 IN PRESSURE RATED MINIBORE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MP5313-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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 3 8.5 in pressure rated minibore set experienced component separation and leaks during use.The following was reported by the initial reporter: "it was reported that the set was leaking blood when the extension set was disconnected from the connector.Verbatim: nsmc ed has reported to mm that they have experienced an issue with the below note item.The issue was with one of the sets leaking blood.(b)(4) set 0.59 8.5in extension maxplus and removable maxiplus cs/50ea when the extension set is disconnected from the connector it will leak because the gasket is not sticking.23-feb-2021 update: photo of packaging- this jlupe is malfunctioning- the plunger on the cap is sticking + leaking x3 on 2/9 c-pob".
Event or Problem Description
It was reported that 3 8.5 in pressure rated minibore set experienced component separation and leaks during use.The following was reported by the initial reporter: "it was reported that the set was leaking blood when the extension set was disconnected from the connector.Verbatim: (b)(6) ed has reported to mm that they have experienced an issue with the below note item.The issue was with one of the sets leaking blood.(b)(4) set 0.59 8.5in extension maxplus and removable maxiplus cs/50ea when the extension set is disconnected from the connector it will leak because the gasket is not sticking.On 23-feb-2021 update: photo of packaging- this jlupe is malfunctioning- the plunger on the cap is sticking + leaking x3 on 2/9 c-pob".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-26.Investigation summary: customer reported there was leaking from the maxplus because the piston was sticking, and returned the affected sample.The set includes a maxplus and extension set.The maxplus was primed with syringe with the extension set and without, and under both circumstances no leak was seen.The set was also tested under 30 psi for 10 seconds while submerged in water, and no leaking was observed.The complaint could not be verified, and the maxplus provided did not have any failures observed.A device history record review for model mp5313-c lot number 20126035 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10dec2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Without a failure, a root cause could not be determined.

• Brand Name: 8.5 IN PRESSURE RATED MINIBORE 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
• MDR Report Key: 11468103
• Report Number: 9616066-2021-50441
• Device Sequence Number: 4523615
• Product Code: FPA
• UDI-Device Identifier: 50885403236714
• UDI-Public: 50885403236714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: MP5313-C
• Device Catalogue Number: MP5313-C
• Device Lot Number: 20126035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1