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

Catalog Number	MX9128
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd maxguard¿ administration sets with needleless y-site experienced tubing separation during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer reported the tubing separates and this has happened when medication is being pushed.Product# mx9128 additional info received on 31-july-23 the most recent incident occurred on 7/7/2023.The other two incidents occurred months ago and i thought it was because the tubing had been somehow accidently pulled apart.".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for device evaluation.One photo was received and analyzed by our quality team.The complaint of separation was immediately verified as it is prominent in photo below the ysite connector.The manufacturing team was contacted for further investigation.The root cause is most likely due to improper application of solvent by operator while assembling the set at the production facility.A quality alert was initiated after the assembly of this lot that trained involved personnel on proper solvent assembly.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see h10 manufacture narrative.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17493791
• Report Number: 9616066-2023-01706
• Device Sequence Number: 7293897
• Product Code: FPA
• UDI-Device Identifier: 10885403237621
• UDI-Public: 10885403237621
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/22/2024

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 Catalogue Number: MX9128
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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