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 Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 was separated.The following information was received by the initial reporter with the following : when attempting to place the t-port onto the iv catheter, the clear rotating piece that attaches the two together, is coming completely off of the t-port.The piece is no longer attached to the port in any way and cannot be used.
Additional Manufacturer Narrative
The customer reported the luer collars were falling off, and returned 5 used samples of material mzxt9001, lot 24039349.The sets were visually examined, and the complaint was verified, the collars had separated from the sets.The luer collar had no perceivable defect, and did stay on the luers.However, the collars were also able to be removed under normal pressure.The sample were sent to the plant for further follow-up.The manufacturing plant found the luer collar issue to be unrelated to the manufacturing process.The quality team followed up with the clinical team on the matter, and the regional sales team will work on education to customer.The root cause is a potential user issue.The only reported issue of the luer collar with mzxt5307 or mzxt9001 is with the same customer, no other customers are experiencing the issue in the past year.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.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Correction needed to be made updating annex a code to defective component and updating short description to damaged deformed product.
Event or Problem Description
Correction it was reported that bd maxzero multi fuse extension set with needleless connector was damaged.When attempting to place the t-port onto the iv catheter, the clear rotating piece that attaches the two together, is coming completely off of the t-port.The piece is no longer attached to the port in any way and cannot be used.

• 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: 19855122
• Report Number: 9616066-2024-01074
• Device Sequence Number: 6821097
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: (01)10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 24039349
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 08/06/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 07/31/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown