MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 17 INCH EXT W/.2 FLTR & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20028E
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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.
Event or Problem Description
It was reported when using the bd 17 inch ext w/.2 fltr & vlv port, the device experienced air bubbles in the line.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the filter is not filtering.We are still having issues with the 0.2-micron filters not filtering.
Event or Problem Description
It was reported when using the bd 17 inch ext w/.2 fltr & vlv port, the device experienced air bubbles in the line.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the filter is not filtering.We are still having issues with the 0.2-micron filters not filtering.
Additional Manufacturer Narrative
H6: investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.An infusion was started using an alaris pump (dchu-0010 and module dchu-0013) at 10 ml/hr for 1 hr.The infusion run completed and the set was inspected for air.No air was observed in the sample.The customer complaint that the filter is not filtering could not be replicated.A device history record review for model 20028e lot number 21049605 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 26apr2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause could not be determined because the issue could not be replicated.

• Brand Name: BD 17 INCH EXT W/.2 FLTR & VLV PORT
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12800997
• Report Number: 9616066-2021-52413
• Device Sequence Number: 20204775
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 12/10/2021

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: Other
• Device Expiration Date: 04/26/2024
• Device Catalogue Number: 20028E
• Device Lot Number: 21049605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown