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

Catalog Number	42511E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 smartsite gravity set was occluded the following information was received by the initial reporter with the following verbatim it was reported by the customer that when nurses spike a bag of fluids, the fluids will not run through the tubing.
Additional Manufacturer Narrative
The customer reported the tubing was occluded when priming, with 5 instances, and returned several boxes of 360 unused samples.This is all of material 42511e, lot 24109336.One box of 60 samples was used as the spot check for the issue.The samples were infused with water from a 10ml syringe to test.All of the 60 representative samples were able to infuse water, and none of them were able to verify the complaint of flow issues.Only 60 samples were tested due to bd internal process for sample size selection.The root cause for the occlusion was unable to be found without a replicated failure.It should be noted this is the first complaint of flow issues - occlusion on this material and lot in the last year.A device history record review 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 SMARTSITE GRAVITY PUMP 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: 22886671
• Report Number: 9616066-2025-02540
• Device Sequence Number: 21046111
• Product Code: FPA
• UDI-Device Identifier: 10885403235412
• UDI-Public: (01)10885403235412(17)271022(10)24109336
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 12/18/2025

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: 42511E
• Device Lot Number: 24109336
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown