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

Catalog Number	MZ9313
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by customer that they were having issues with fluid flow with the product.One sample was received for quality evaluation.Visual inspection of the sample did not indicate any damages or abnormalities.A line flush was attempted on each fluid line with a bd needleless syringe and water.One of the lines did not allow for fluid flow.Further examination under magnification indicates that there is an occlusion in the fluid path obstructing flow.The customer complaint of flow issues - fluid blockage was confirmed.Further investigation indicates the most potential root cause, that generated the occlusion in the tubing/trifurcate engagement, is an incorrect application of bonding solvent between the tubing and the female connector causing the occlusion.A quality alert was issued to the production personnel along with updating the standard work instruction to address this issue.
Event or Problem Description
It was reported that bd maxzero extension set was occluded the following information was received by the initial reporter with the following.It was reported by customer that they had about 4 issues with this product two of them involved tpn delivery.

• Brand Name: BD MAXZERO 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: 25710680
• Report Number: 9616066-2026-01693
• Device Sequence Number: 18802644
• Product Code: FPA
• UDI-Device Identifier: 10885403471292
• UDI-Public: (01)10885403471292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: MZ9313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown