MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. De C.V. BD Alaris extension Set; Intravascular administration set

Catalog Number	11088483
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sample investigation.
Additional Manufacturer Narrative
It was reported by a customer that the tubing would not flush.They checked all connections and tried to flush tubing again with no success.Then got additional tubing from supply closet and tried to flush with no success.Three samples were submitted for quality evaluation.Flushing the extension sets with water was attempted using a sample bd syringe.The samples did not allow for any fluid flow through the sample.Examination under magnification was conducted and an occlusion in the infusion line was identified at the female luer adapter.The customer complaint of flow issues - fluid blockage was confirmed.Further investigation of the samples indicates that the root cause of the issue was determined to be a double insertion of the extension set into the solvent dispenser causing the occlusion.A complaint history check was conducted in order to determine if there is a trend in the issue.It was determined that the issue was an isolated case and current control systems are appropriate to avoid the issue for future production.We will continue to track conditions reported and proper action will be deemed necessary.A device history record review for model 11088483 lot number 26045109 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. De C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50021584
• Report Number: 9616066-2026-01872
• Device Sequence Number: 10540045
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/22/2026

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: 11088483
• Device Lot Number: 26045109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown