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

Catalog Number	MX9968
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd maxguard administration set with needleless y-site(s) luer lock collar broke during disconnecting and caused leakage.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.P injuries or adverse event: no.Reported issue: distal port causes sticking of 40" iv secondary rotating male luer lock.Upon attempting to disconnect, luer lock breaks and if the primary line is not clamped, all fluids rush out.This has happened 3-4 times so far.
Event or Problem Description
It was reported that bd maxguard administration set with needleless y-site(s) luer lock collar broke during disconnecting and caused leakage.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.P injuries or adverse event: no reported issue: distal port causes sticking of 40" iv secondary rotating male luer lock.Upon attempting to disconnect, luer lock breaks and if the primary line is not clamped, all fluids rush out.This has happened 3-4 times so far.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of component damage (no leak) could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.H3 other text : see h10.

• Brand Name: BD MAXGUARD ADMINISTRATION 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17790005
• Report Number: 9616066-2023-01917
• Device Sequence Number: 6169923
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: (01)50885403237803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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 Catalogue Number: MX9968
• Device Lot Number: 0332303A073
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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