MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE; 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	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.The initial reporter also notified the fda.Medwatch report # mw5114542.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd maxguard¿ flow controller extension set with needleless y-site the medication was able to be primed, however, after flow dial was set the medication was occluded.There was no report of patient impact.The following information was provided by the initial reporter: maxguard flow controller set x 2 defective.Able to prime medication, but after flow dial set, medication would no longer flow through the extension.
Event or Problem Description
It was reported that during use with bd maxguard¿ flow controller extension set with needleless y-site the medication was able to be primed, however, after flow dial was set the medication was occluded.There was no report of patient impact.The following information was provided by the initial reporter: maxguard flow controller set x 2 defective.Able to prime medication, but after flow dial set, medication would no longer flow through the extension.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the medication will not flow through the set.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model mfs141 lot number 22039077 was performed.There was a quality notification issued for the failure mode reported by the customer during the production build of this set for the lot 22039077 on (b)(6) 2022.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD MAXGUARD¿ FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE
• 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: 16492820
• Report Number: 9616066-2023-00330
• Device Sequence Number: 6316256
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: 10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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?: No
• 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: 03/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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