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

Catalog Number	10015171
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
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 alaris smartsite gravity set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that when stabbing into the thawed product with the car t spike into the car- t product, as they inverted it, saw that there was a leak below the spike in the base of the spike.Noted a drip, re-inverted it.The stem cell processing lab had to cut the tubing below the drip chamber to determine the amount of product loss, will find a hemostat in place at the point of the tubing manipulation.They lost 2.3 mls of carvykti product.The leak occurred below the tubing spike but above the drip chamber.This was noted immediately upon spiking the bag.
Additional Manufacturer Narrative
The customer reported the spike was leaking at the base of the drip chamber, and returned one sample of material 10015171, lot 24079363.Upon initial visual examination, the set was separated (cut) at one of the two drip chambers, as reported by the customer.The drip chamber was cut off by the customer after a leak was found between the spike and drip chamber.The drip chamber was then sent out for further analysis to the supplier of the drip chamber.The drip chamber is a supplied component and was sent us for further evaluation to the supplier.Their investigation involved an underwater air-pressure leak test to check for bubbles.This test did not reveal any leakage, and the complaint could not be verified.The root cause for the issue is unknown without the verified failure.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 ALARIS SMARTSITE GRAVITY 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: 21458769
• Report Number: 9616066-2025-00333
• Device Sequence Number: 7986919
• Product Code: FPA
• UDI-Device Identifier: 10885403233975
• UDI-Public: (01)10885403233975(11)240715(17)270715(10)24079363
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 04/09/2025

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: 10015171
• Device Lot Number: 24079363
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown