MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. NDLELESS VLV ADPT ARTERIAL; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2000EA
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20105313.Medical device expiration date: 2023-10-13.Device manufacture date: 2020-09-30.Medical device lot #: 21035205.Medical device expiration date: 2024-03-02.Device manufacture date: 2021-03-01.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 ndleless vlv adpt arterial had flow issues.The following information was provided by the initial reporter: it was reported that they are having issues with smartsite needle-free valves not allowing anything to flow through.
Additional Manufacturer Narrative
H.6.Investigation: one sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a cut off bd syringe to see if a fluid path can be observed while the piston is in the activated position.A fluid path was observed while the piston was in the activated position.The smartsite was then connected to a 10 ml bd syringe filled with blue dye water and the set was attempted to be flushed.The set was successfully flushed.The customer complaint that they are having issues with smartsite needle-free valves not allowing anything to flow through could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 2000ea lot number 221035205 and 220105313 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of these sets.Capa#1998036 has been initiated.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of flow issues - fluid blockage with lot #20105313 regarding item #2000ea.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #21035205 regarding item #2000ea.H3 other text : see h.10.
Event or Problem Description
It was reported that ndleless vlv adpt arterial had flow issues.The following information was provided by the initial reporter: it was reported that they are having issues with smartsite needle-free valves not allowing anything to flow through.

• Brand Name: NDLELESS VLV ADPT ARTERIAL
• 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: 12008598
• Report Number: 9616066-2021-51321
• Device Sequence Number: 17219886
• Product Code: FPA
• UDI-Device Identifier: 07613203012751
• UDI-Public: 07613203012751
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/21/2021

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 Catalogue Number: 2000EA
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1