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

Model Number	11582774
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ secondary set leaked from the bottom of the drip chamber.The following information was provided by the initial reporter: "leaking at bottom of drip chamber of tubing".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-feb-10.H6: investigation summary the customer reported the tubing was leaking from the bottom of the drip chamber and returned 2 photos and 14 unused samples of material #11582774.The 14 unused samples were tested at the drip chamber for solvent issues that would cause a leak and none were found.All 14 samples did not separate at the drip chamber.The complaint is verified by the 2 photos returned of separated drip chambers.Based on previous similar complaints manufacturing provided feedback that a project has been funded to address the issue.There is a known issue for drip chamber separations that is being addressed in a project.A device history record review for model 11582774 lot number 21109210 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris¿ secondary set leaked from the bottom of the drip chamber.The following information was provided by the initial reporter: "leaking at bottom of drip chamber of tubing".

• Brand Name: BD ALARIS¿ SECONDARY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13482868
• Report Number: 9616066-2022-00091
• Device Sequence Number: 20199271
• Product Code: FPA
• UDI-Device Identifier: 50885403234758
• UDI-Public: 50885403234758
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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 Model Number: 11582774
• Device Catalogue Number: 11582774
• Device Lot Number: UNKNOWN
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown