MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	20019E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 20115015.Medical device expiration date: 2023-11-05.Device manufacture date: 2020-11-03.Medical device lot #: 20066231.Medical device expiration date: 2023-06-16.Device manufacture date: 2020-06-11.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 y ext w/vlv ports & 2 sld clp set from lot 20115015, 1 set from lot 20066231, and 1 set from an unspecified lot had issues with fluid blockage/flow issues during use.The following information was provided by the initial reporter: "we have had several of these sets fail.The problem is that we can't flush both ends with out manipulating the valves.".
Event or Problem Description
It was reported that 1 y ext w/vlv ports & 2 sld clp set from lot 20115015, 1 set from lot: 20066231, and 1 set from an unspecified lot had issues with fluid blockage/flow issues during use.The following information was provided by the initial reporter: "we have had several of these sets fail.The problem is that we can't flush both ends with out manipulating the valves.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.A device history record review for model: 20019e, lot number: 20066231 and 20115015 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause was unable to be determined.Capa#: 1998036 was initiated.The complaint could not be confirmed and the root cause is undetermined.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#: 20115015 regarding item: 20019e.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#: 20066231 regarding item: 20019e.

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• 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: 11586877
• Report Number: 9616066-2021-50599
• Device Sequence Number: 19860657
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• 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): 04/29/2021

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: Other
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1