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	MZXT9001
Medical Device Problem Codes	Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero multi fuse extension set with needleless connector separated the following information was received by the initial reporter with the following verbatim: verbatim: product problem - the t connector comes apart and is not secure.- multiple patients.
Additional Manufacturer Narrative
Two samples of item mzxt9001 were submitted for quality evaluation.Visual examination shows that one of the samples had the securement collar removed from the t-connector body, and the second sample showed that the securement collar was loose on the t-connector body and was easily removed.The customer complaint of separation was confirmed by investigation.The investigation was forwarded to the manufacturing facility for determination of the root cause of the failure.After the investigation it was determined that the possible root cause is that the molding cavity of the component was out of specification.Containment of the components was conducted for batches of the component related to the components reported.Additionally, a work order was issued to update the molding cavities to correct the component moldings to specifications, and a quality alert was issued to communicate the issue to the personnel involved in the molding process and to re-emphasize the importance of following the assembly instructions.Finally the issue was escalated to our corrective and preventative action system and actions have been taken and will be tracked to ensure the actions taken have addressed the reported issue.
Event or Problem Description
Material # mzxt9001.Batch # 24049250.It was reported by customer that the t connector comes apart and is not secure.Verbatim: product problem - the t connector comes apart and is not secure.- multiple patients.Item -mzxt9001.Lot -24039340.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20351874
• Report Number: 9616066-2024-01420
• Device Sequence Number: 7926584
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: (01)10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: MZXT9001
• Device Lot Number: 24049250
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown