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

Catalog Number	MZ5313
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
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 extension set was loose.The following information was received by the initial with the following verbatim it was reported by the customer that this product is too heavy which dislodges ivs.There are 2 injection ports which has higher risk of infection.The needleless injection port was loose which resulted in blood flowing back into the patient bed.
Additional Manufacturer Narrative
No photo or sample was received for the customer's complaint of loose component/ connection issues and leak.The complaint cannot be verified, and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.A device history record review could not be performed because a lot number was not provided by the customer.(the provided lot number did not match any records, most likely due to an omission of a number).

• 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: 22235252
• Report Number: 9616066-2025-01599
• Device Sequence Number: 18189092
• Product Code: FPA
• UDI-Device Identifier: 10885403471261
• UDI-Public: (01)10885403471261
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/27/2025

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: MZ5313
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown