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

Model Number	MV0400
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that at least one bd smartsite¿ vented vial access device experienced device damage while still considered operable.The following information was provided by the initial reporter: when using 1ml vials for benadryl and fentanyl, the mv0400 universal vial access device has repeatedly failed to pierce the septum and the entire septum is pushed into the drug.
Additional Manufacturer Narrative
Information received via investigation closure.The information provided below shows the updated fields below.D.9 device received : yes.D.9 returned to manufacturer on: apr-08-2022.H.6.Investigation summary: two unused samples were returned for investigation.Through visual inspection, no defects or damages were observed on the samples.The spikes were used to poke through infusion bag and were able to without inserting the whole spike into the bag.The supplier was notified of this defect and an investigation was performed.A device history record review was completed for mv0400 lots 212019 and 9240, and there were no nmrs, capas / deviations generated or reported anomalies during the production of this lot.There have been no other complaints associated with this lot.Based on past experience, previous testing to recreate reported problems, and knowledge of the device, the reported issue could be due to an incorrect vial access attachment procedure, drug vial/stopper incompatibility, inadequate / improper drug vial crimping or a manufacturing defect.
Event or Problem Description
It was reported that at least one bd smartsite¿ vented vial access device experienced device damage while still considered operable.The following information was provided by the initial reporter: when using 1ml vials for benadryl and fentanyl, the mv0400 universal vial access device has repeatedly failed to pierce the septum and the entire septum is pushed into the drug.

• Brand Name: BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE
• Common Device Name: IV FLUID TRANSFER SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13426582
• Report Number: 9616066-2022-00059
• Device Sequence Number: 3744032
• Product Code: LHI
• UDI-Device Identifier: 10885403221644
• UDI-Public: 10885403221644
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Model Number: MV0400
• Device Catalogue Number: MV0400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown