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

Catalog Number	MZ9325
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
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 extension set broke the following information was received by the initial reporter with the following verbatim it was reported by customer that the spin collar cracked off hub of extension set when nurse checked infusion.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual examination of the sample was conducted an the male luer adapter is missing its securement collar.Further examination of the component shows that there is a crack in the adapter manifold body.The customer complaint of component damage ¿ leak was confirmed.The investigation was forwarded to the luer connector supplier for further evaluation.Based on the findings of the investigation, and review of the component and full assembly processes, it was determined that the issue was not caused during each of those processes.Further evaluation of the sample indicates that the issue may have been caused by the customer using an antiseptic on the luer surfaces and not allowing the surfaces to dry completely, creating an issue where the luers connections can adhere together.When trying to disconnect this connection afterwards, the luer connection can crack.The root cause for the issue is likely a user issue.A device history record review for model mz9325 lot number 24099166 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 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: 21918527
• Report Number: 9616066-2025-01035
• Device Sequence Number: 18342011
• Product Code: FPA
• UDI-Device Identifier: 10885403427244
• UDI-Public: (01)10885403427244(11)240905(17)270905(10)24099166
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Followup
• Report Date (Section B): 07/29/2025

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: MZ9325
• Device Lot Number: 24099166
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown