MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 105"ADMIN SET 20DP W/FILTER 2YSITES CLMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70072-F
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: dhr review.Model: b2-70072-f.Lot number: 20063534.Qty: 3,000.Qn/deviation: zero.Mfg date: may/26/2020.No qn¿s were found for the reported lot.Trend review: a trend review was performed for model b2-70072-f and no qns related to this failure mode were found in a 12-months period (june 15th, 2020 to june 15th, 2021).A trend review was performed for model b2-70072-f and no additional complaint related to this failure mode was found in a 12-months period (june 15th, 2020 to june 15th, 2021).Investigation summary: a picture of the filter in the b2-70072-f was shared by customer, in the photo the filter was observed with and arrow pointing a side of the filter.According with the picture, the filter is not showing any leak, also, no traces of medication was observed.Samples were requested, but according with the customer, the samples was not available, since no sample was received for evaluation, and the picture is not showing the leak, therefore, it wasn¿t able confirm the leakage in the filter.Root cause definition: a picture of the filter in the b2-70072-f was shared by customer, according with the picture, the filter is not showing any leak and since no sample was received for evaluation, the failure mode could not be confirmed.Corrective and preventive actions: no preventive and corrective actions required since the failure mode could not be confirmed.We will continue to monitor our customer feedback processes for any similar incidences, implement any corrective actions as appropriate.
Event or Problem Description
It was reported that the 105"admin set 20dp w/filter 2ysites clmp experienced leakage.The following information was provided by the initial reporter: material no: b2-70072-f.Batch no: 20036534.It was reported by the nurse that this set leaked.Patient was not harmed.Event date; (b)(6) 2021.

• Brand Name: 105"ADMIN SET 20DP W/FILTER 2YSITES 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: 12054788
• Report Number: 9616066-2021-51374
• Device Sequence Number: 3465169
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• 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
• Report Date (Section B): 06/11/2021

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 Expiration Date: 03/26/2023
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 20036534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1