MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD DROP ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4436
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd maxguard drop administration set there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: item will not prime.
Event or Problem Description
It was reported while using bd maxguard drop administration set there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: item will not prime.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 01-nov-2022 h.6.Investigation summary: two samples for model # mx4436 were returned from the customer.It was reported by customer that while using the bd primary gravity iv administration sets the product would not prime was observed.Prior to functional testing the sets were visually examined for defects and abnormalities.No other defects or abnormalities were observed.Sets were attached to an iv bag filled with water but was not able to prime because of the blue back check valve put on backwards causing injected medication to flow up the iv bag rather than to the patient.So there is an issue of misassembly of the blue check valve which was observed to be assembled upside down.A quality notification was sent to the manufacturer.A device history record review for model # mx4436 and lot number 22019801 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29aug2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot #2019801 the root causes of this complaint were determined to be no orientation fixture is used and no sequence of operation is followed.A quality alert will be created to prevent this defect.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD MAXGUARD DROP ADMINISTRATION SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15802552
• Report Number: 9616066-2022-01742
• Device Sequence Number: 12166478
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: 10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 11/29/2022

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: 01/07/2025
• Device Catalogue Number: MX4436
• Device Lot Number: 22019801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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