MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ADMIN SET 20DP W/ FILTER Y SITE CLMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70071-DF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 2 admin sets 20dp w/ filter y site clmp leaked from the filter near the patient during use.The following information was provided by the initial reporter: "on (b)(6) 2021 a user reported that an administration set model b2-70071-df, lot 20085018 was leaking at the filter closest to the patient.It happened on two separate occasions (second separate complaint will be sent).Operator rn.Medication entyvio.Patient involved.Patient not harmed.User is unsure of the exact date.Happened over the last couple of weeks.".

• Brand Name: ADMIN SET 20DP W/ FILTER Y SITE CLMP
• 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: 11548124
• Report Number: 9616066-2021-50529
• Device Sequence Number: 19787111
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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 Expiration Date: 08/20/2023
• Device Model Number: B2-70071-DF
• Device Catalogue Number: B2-70071-DF
• Device Lot Number: 20085018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1