MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9275
Medical Device Problem Codes	Crack (1135); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photo or sample was received for the customer's complaint of separation.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.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.
Event or Problem Description
It was reported that during use with bd maxzero¿ multi-fuse extension set with needleless connector it disconnected from fem line and the threaded collar connector was cracked.The following information was provided by the initial reporter: bd maxzero quad-fuse disconnected to draw labs from fem line.Upon reconnecting, the threaded collar connector cracked.Remained secured on the fem line, but upon inspection several cracks were seen throughout collar.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 28-feb-2023.H6: investigation summary 2 samples were received and tested by our quality team.The male luers were visually analyzed and one had a collar completely broken while the other was visibly cracked verifying the complaint.A microscope was used to further analyze and the collars were clearly crushed by a significant force.The manufacturer was contacted for further investigation into the root cause.There is a possible root cause of damage during packaging process but without the packaging material or the lot this is impossible to determine- the root cause remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that during use with bd maxzero¿ multi-fuse extension set with needleless connector it disconnected from fem line and the threaded collar connector was cracked.The following information was provided by the initial reporter: bd maxzero quad-fuse disconnected to draw labs from fem line.Upon reconnecting, the threaded collar connector cracked.Remained secured on the fem line, but upon inspection several cracks were seen throughout collar.

• Brand Name: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 16463646
• Report Number: 9616066-2023-00282
• Device Sequence Number: 12399086
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: 10885403240768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 04/05/2023

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: MZ9275
• Device Lot Number: UNKNOWN
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/11/2023
• 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