MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Model Number	MFS141
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) clogged.The following information was provided by the initial reporter: failure: flow issue ¿ occlusion.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Address information was not able to be obtained, therefore, nj was used as a place holder.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxguard flow controller extension set with needleless y-site(s) clogged.The following information was provided by the initial reporter: failure: flow issue ¿ occlusion.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 10-mar-2023.H6: investigation summary: two samples of mfs141 and one concomitant sample of 72213n were received for quality investigation.The customer complaint of flow issues - fluid blockage was verified by inspection.The sample 72213n was primed and examined for any damage or flow issues.There were no issues with the 72213n submitted.The 72213n was then connected to the first sample of the mfs141 valve, and it did not allow for fluid flow through the assembly.The first sample of mfs141 was then removed and the second sample was connected to the 72213n set.The second sample of mfs141 did not allow fluid flow through the assembly as well.There were no other issues of leakage or air in line.A device history record review for model mfs141, lot number: 22039077 was performed.A quality notifications was issued for the failure mode reported by the customer for the production build of this set.The root cause for the issue is the failure of the flow control valve assembly to allow fluid flow.

• Brand Name: BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS 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: 16483444
• Report Number: 9616066-2023-00328
• Device Sequence Number: 5263036
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: (01)10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/29/2023

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 Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: UNKNOWN
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/04/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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