MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD; 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	11/18/2022
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 that 3 bd maxguard extension set with needleless y-site(s), stopcock(s) and manifold was clogged.The following information was provided by the initial reporter: description of event(s) will not prime.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-dec-2022.H6: investigation summary three samples for model # mx4436 were returned from the customer.It was reported by customer that "will not prime".Prior to functional testing the sets were visually examined and no defects or abnormalities were found.Testing was performed in all of the samples by attempting to prime the set using a saline bag.Two sets were unable to prime.For the sets that were unable to prime, each y-site in the tubing set was attempted to be flushed by using 10 ml bd syringe with water.The y-sites were able to be flushed successfully.For further testing each smart site was cut down turn by turn but no flow was observed.Then the tube between the blue check valve and drip chamber was cut and liquid started flowing easily.The distal end of the blue check valve was examine under magnification and no excess solvent observed in it.The customer complaint could be replicated.The manufacturing team was notified and a production process review will be performed.A device history record review for model mx4436 and lot number 22085391 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.The possible root cause of this complaint failure mode is not evident, therefore a production process review with unknown root cause will be carried out to identify any opportunity.
Event or Problem Description
It was reported that 3 bd maxguard extension set with needleless y-site(s), stopcock(s) and manifold was clogged.The following information was provided by the initial reporter: description of event(s) will not prime.

• Brand Name: BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S), STOPCOCK(S) AND MANIFOLD
• 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: 15982987
• Report Number: 9616066-2022-01957
• Device Sequence Number: 20307343
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/27/2023

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: 08/11/2025
• Device Catalogue Number: MX4436
• Device Lot Number: 22085391
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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