MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 3-PORT MANIFOLD W/EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20519E
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 3-port manifold w/ext set was difficult to disconnect lines and had a crack.The following information was provided by the initial reporter: it was reported that the item is difficult to crew and unscrew lines from and sometimes crack.Verbatim: the icu staff has had some concerns and complaints about our current iv manifolds that we have.They have informed me that they are difficult to screw and unscrew lines from and sometimes crack.I would like to change the product we are using.

• Brand Name: 3-PORT MANIFOLD W/EXT SET
• 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: 12028502
• Report Number: 9616066-2021-51349
• Device Sequence Number: 11106687
• Product Code: FPA
• UDI-Device Identifier: 10885403234941
• UDI-Public: 10885403234941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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
• Report Date (Section B): 06/14/2021

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 Catalogue Number: 20519E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1