MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE 20MM VENTED VIAL ACCESS DEVICE; I.V. FLUID TRANSFER SET

Model Number	MV0420
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.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 smart-site 20mm vented vial access device leaked.The following information was provided by the initial reporter: material no: mv0420; batch no: unknown.It was reported that while attaching this device to our 20mm vial, the device did not pierce the stopper, but inadvertently pushed the stopper into the vial.
Additional Manufacturer Narrative
H.6.Investigation: no photo or sample received for investigation, the customer's complaint of faulty vial/stopper could not be verified at this time.A device history record review could not be performed because a lot number was not provided by the customer.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 smartsite 20mm vented vial access device leaked.The following information was provided by the initial reporter: material no: mv0420 , batch no: unknown.It was reported that while attaching this device to our 20mm vial, the device did not pierce the stopper but inadvertently pushed the stopper into the vial.

• Brand Name: SMARTSITE 20MM VENTED VIAL ACCESS DEVICE
• Common Device Name: I.V. FLUID TRANSFER 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: 10710185
• Report Number: 9616066-2020-20141
• Device Sequence Number: 3259615
• Product Code: LHI
• UDI-Device Identifier: 10885403228452
• UDI-Public: 10885403228452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122265
• 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): 10/29/2020

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: 06/28/2022
• Device Model Number: MV0420
• Device Catalogue Number: MV0420
• Device Lot Number: 9226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1