MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX5301
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 that during use with an unspecified amount of bd maxguard¿ pressure rated extension set with y-site(s) 5 the lines are clogged.This is the 1st of 2 complaints.The following information was provided by the initial reporter: we have had trouble with the new iv extension sets since we switched to them a few months ago.The bd maxguard pressure rated extension sets work most of the time, but there have been multiple incidents where ivs won't run well or flush, we are unable to bolus iv fluid or push meds on some of the devices.
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: 05-jun-2023.H.6.Investigation summary: the customer reported leaking from the hub, and returned one used sample.The sample was tested with water in the lab, and no leakage was found.The set flushed without any issue, and was able to connect water-tight to other sets in the lab.The complaint could not be verified, and the root cause is unknown.Device history record review for model mx5301 lot number 23039035 was performed.The search showed that a total of 38,403 units in 1 lot number was built on 02mar2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.
Event or Problem Description
It was reported that during use with an unspecified amount of bd maxguard¿ pressure rated extension set with y-site(s) 5 the lines are clogged.This is the 1st of 2 complaints.The following information was provided by the initial reporter: we have had trouble with the new iv extension sets since we switched to them a few months ago.The bd maxguard pressure rated extension sets work most of the time, but there have been multiple incidents where ivs won't run well or flush, we are unable to bolus iv fluid or push meds on some of the devices.

• Brand Name: BD MAXGUARD¿ PRESSURE RATED EXTENSION SET WITH Y-SITE(S)
• 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 ; 8448235433
• MDR Report Key: 17148730
• Report Number: 9616066-2023-01200
• Device Sequence Number: 5771582
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: (01)10885403237553
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/25/2023

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: 03/02/2026
• Device Catalogue Number: MX5301
• Device Lot Number: 23039035
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 10/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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