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

Model Number	MX9968
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd maxguard¿ administration set with needleless y-site experienced separation.The following information was provided by the initial reporter: in april, a paramedic went to spike a bag of iv fluid and tubing (re# mx9968 lot# 22019189) just sort of fell out of chamber.
Additional Manufacturer Narrative
H6: investigation summary a sample was received and tested by our quality team.The drip chamber to tubing separation was immediately noticed and the customer's complaint was verified.Visual analyses under microscope determined the root cause to be lack of solvent at the tubing to drip chamber junction during assembly.A device history record review for model mx9968 lot number 22019189 was performed.The search showed that a total of 14,403 units in 1 lot number was built on 21jan2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that the bd maxguard¿ administration set with needleless y-site experienced separation.The following information was provided by the initial reporter: in april, a paramedic went to spike a bag of iv fluid and tubing (re# mx9968 lot# 22019189) just sort of fell out of chamber.

• Brand Name: BD MAXGUARD¿ ADMINISTRATION 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 ; 8015296192
• MDR Report Key: 15174884
• Report Number: 9616066-2022-01060
• Device Sequence Number: 12349306
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: 50885403237803
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/23/2022

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 Model Number: MX9968
• Device Catalogue Number: MX9968
• Device Lot Number: 22019189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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