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

Model Number	A2-80071-DF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the admin set 20 dp, w/ filter y site leaked from the filter during use.The following information was provided by the initial reporter: "stated that an administration set model a2-80071-df, lot 18036934 set was leaking at the filter.Operator rn.Medication unknown.Patient involved.Patient was not harmed.(b)(6) 2020".
Additional Manufacturer Narrative
H.6.Investigation: one sample of the a2-80071-df was received on december 17th, 2020, it was tested and the leak in filter was confirmed and since it was related to a supplier component the investigation was requested to a supplier from the supplier quality engineer hector figueroa.Customer return sample was evaluated and the leak was confirmed from weld area.The part did go through the welding operation as weld line was visible around the part while the area of leak was not welded at the time of testing.Part being 3 year old, there's no way to adequately identify what could have caused the filter to un-weld.Dhr review of lot #141009 was conducted and no changes/rejections were identified which could have caused a weaker weld.Actual root cause from the manufacturing process could not be identified from reviewing the part, dhr or maintenance log.H3 other text : see h.10.
Event or Problem Description
It was reported that the admin set 20 dp, w/ filter y site leaked from the filter during use.The following information was provided by the initial reporter: "stated that an administration set model a2-80071-df lot 18036934 set was leaking at the filter.Operator rn.Medication unknown.Patient involved.Patient was not harmed.(b)(6) 2020".

• Brand Name: ADMIN SET 20 DP, W/ FILTER Y SITE
• 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 22244 ; MX 22244
• MDR Report Key: 10989258
• Report Number: 9616066-2020-20555
• Device Sequence Number: 10950753
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 03/26/2021
• Device Model Number: A2-80071-DF
• Device Catalogue Number: A2-80071-DF
• Device Lot Number: 18036934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1