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	05/27/2021
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 #: 20125630.Medical device expiration date: unknown.Device manufacture date: 2020-12-03.Medical device lot #: 20125454.Medical device expiration date: 2023-12-03.Device manufacture date: 2020-12-01.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 3 y ext w/vlv ports & 2 sld clp experienced flow issues and were clogged during use.The following was reported by the initial reporter: "one of the bungs is faulty, as you cannot flush, there is no movement, i have marked the line with a black marker.".
Event or Problem Description
It was reported that 3 y ext w/vlv ports & 2 sld clp experienced flow issues and were clogged during use.The following was reported by the initial reporter: "one of the bungs is faulty, as you cannot flush, there is no movement, i have marked the line with a black marker.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/14/2021.H.6.Investigation: four 20019e7d samples were received in open packaging for investigation; two samples were from lot 20125454 and two were from lot 20125630.All four samples were received with residual fluid present in the line.No connecting products were returned to assist the investigation.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to the 20019e7d samples; in each instance no flow restrictions or occlusions were identified.A review of the production records for lot 20125454 and 20125630 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned samples did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.H3 other text : see h.10.

• 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: 12054173
• Report Number: 9616066-2021-51366
• Device Sequence Number: 19699250
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: Health Professional
• Device Model Number: 20019E
• Device Catalogue Number: 20019E7D
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1