MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZX5306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero pressure rated extension set was separated the following information was received by the initial reporter with the following verbatim it was reported by the customer that " tested one to see how much force i needed to pull it apart and needed to put some strength into it, thinking maybe the connection is weak but it is pretty solid.Iv site itself remained intact and confirmed there was no pulling or manipulating of the iv line".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One photo was received for quality evaluation.Inspection of the photo indicates that the product separated at the inlet port of the y-site connector.The customer complaint of separation was confirmed.The investigation was forwarded to manufacturing for root cause analysis.After the investigation, the separation between tubing and the nac-y connector could be related to an incorrect solvent application by the assembler or issues with the solvent dispenser.The manufacturing location for the product and reported batch number, will no longer be producing the product.Therefore, no corrective actions were taken at that manufacturing location.A quality alert for the same product was created to communicate the defect and reinforce the correct solvent application between components and follow-up to work instruction as issued at the remaining production location to avoid similar issues.A device history record review for model mzx5306 lot number 25019344 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXZERO PRESSURE RATED EXTENSION SET
• 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: 24491874
• Report Number: 9616066-2026-00551
• Device Sequence Number: 16111786
• Product Code: FPA
• UDI-Device Identifier: 10885403463792
• UDI-Public: (01)10885403463792(17)280117(10)25019344
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• 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
• Report Date (Section B): 03/03/2026

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: MZX5306
• Device Lot Number: 25019344
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown