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	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no investigation was performed since no sample was received for evaluation.Dhr review model: b2-70071-df, lot number: 20085018, lot quantity: (b)(4), qn: zero, q7: zero, mfg date:aug/20/2020.No qn was found during manufacturing of the lot reported in this complaint.Root cause definition: no root cause definition was determined due to the customer did not provided a sample for evaluation and lot number.Corrective and preventive actions no preventive and corrective actions required due to no sample was received for evaluation.
Event or Problem Description
It was reported that 2 admin sets 20dp w/ filter y site clmp leaked at the filter during use.This complaint was created to capture the 1st of 2 related incidents.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.Operator rn.Medication entyvio.Patient involved.Patient not harmed.User is unsure of the exact date.Happened over the last couple of weeks.".
Event or Problem Description
It was reported that 2 admin sets 20dp w/ filter y site clmp leaked at the filter during use.This complaint was created to capture the 1st of 2 related incidents.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.Operator rn.Medication entyvio.Patient involved.Patient not harmed.User is unsure of the exact date.Happened over the last couple of weeks.".
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.H3 other text : see h10.

• 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: 11729537
• Report Number: 9616066-2021-50816
• Device Sequence Number: 3437298
• 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,Followup
• Report Date (Section B): 06/16/2021

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
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1