MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE VIALSHIELD 20MM CLOSED VAD; INTRAVASCULAR ADMINISTRATION SET

Model Number	MV0520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2020
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.(b)(4).
Event or Problem Description
It was reported that a smartsite vialshield 20mm closed vad experienced component separation during use.The following was reported by the initial reporter: "it was reported that the textium vial topper broke when attempting to disconnect the syringe.Verbatim: earlier today we had a situation where the an mv-20 texium vial topper broke when attempting to disconnect the texium syringe from the vial topper.".
Additional Manufacturer Narrative
H.6.Investigation: no physical sample was received but analyses of customer provided photos lead to believe that an insufficient solvent (loctite) may have been used during assembly of product.This would end with the customer's reported failure at the junction reported.Despite numerous attempts being made to attain the dhr information for material#: mv0520, batch/lot #: 202015.No information was made available.Root cause unknown without a physical sample for investigation but suspect lack of solvent loctite may have led to reported separation.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation with lot #202015 regarding item #mv0520.
Event or Problem Description
It was reported that a smartsite vialshield 20mm closed vad experienced component separation during use.The following was reported by the initial reporter: "it was reported that the textium vial topper broke when attempting to disconnect the syringe.Verbatim: earlier today we had a situation where the an mv-20 texium vial topper broke when attempting to disconnect the texium syringe from the vial topper.".

• Brand Name: SMARTSITE VIALSHIELD 20MM CLOSED VAD
• 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: 10989260
• Report Number: 9616066-2020-20553
• Device Sequence Number: 752666
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• Number of Events Summarized: 1
• Summary Report (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): 01/26/2021

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: 05/28/2023
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 202015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1