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

Catalog Number	10012866
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris extension set was damaged.The following information was provided by the initial reporter: defective and leaking, additional information received from the customer: could you please provide a further description of the issue is there any defect/ issue found apart from leakage? the micron low protein binding filter was found to have started leaking through a small crack.Tpn and lipids were infusing through the filter.This has been reported as happening to multiple filters throughout the past few weeks.Can you please provide an exact date of event in format dd-mm-yyyy? the first reported date was 5/23/2025 and there have been a few after with no date provided.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Examination of the sample shows that there is a crack on the female luer adapter connection that would cause leakage.The customer complaint of component damage was confirmed.The investigation was forwarded to manufacturing for root cause analysis.Based on the examination of the sample, manufacturing could not relate the damage to the manufacturing process.The root cause for the damage could not be determine.A possible cause of the issue may be due to using alcohol or an antiseptic cleaner on the female luer and connecting it before allowing for the alcohol or antiseptic to dry.This can cause the luer body to become brittle and crack when connected.The bd clinical team has been made aware and will be in contact with the customer if further use information or training is determined necessary.A device history record review for model 10012866 lot number 24079416 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 ALARIS EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23417396
• Report Number: 9616066-2025-03316
• Device Sequence Number: 16088513
• Product Code: FPA
• UDI-Device Identifier: 10885403233777
• UDI-Public: (01)10885403233777(17)270718(10)24079416
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 01/19/2026

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: 10012866
• Device Lot Number: 24079416
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown