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

Catalog Number	MP9220-C
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard extension set was damaged the following information was received by the initial reporter with the following verbatim it was reported by customer that the leuer end of the bd maxplus tri-fuse extension set (ref mp-9220-c; lot25019330) was cracked.This was replaced by bd maxzero microbore trifuse extension set (ref mz9266 lot (10)23129280).At blood draw on [date redacted] the next day, the leuer end of this extension set was found to also be cracked.Replaced this with the bd maxzero microbore bifuse extension set (ref mz9265 lot 24119278).Unfortunately, the connection started leaking as soon as the ivf [intravenous fluids] and nahco3 [sodium bicarbonate] infusion was started.
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
No product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review for material#: mp9220-c and lot#: 25019330 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17jan2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD MAXGUARD 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: 22494174
• Report Number: 9616066-2025-01971
• Device Sequence Number: 18170892
• Product Code: FPA
• UDI-Device Identifier: 10885403237003
• UDI-Public: (01)10885403237003(17)280117(10)25019330
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 07/23/2025

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: MP9220-C
• Device Lot Number: 25019330
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 13 YR
• Patient Sex: Male