MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP GEM V/NV 20D 0.2 FLTR; INTRAVASCULAR ADMINISTRATION SET

Model Number	2232-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 of the bd alaris¿ lvp gem v/nv 20d 0.2 fltr experienced leakage.The following information was provided by the initial reporter: leakage.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-apr-2023.Investigation summary: three samples of material number 2232-0007 were submitted for quality investigation.The customer complaint of leakage was verified by inspection.The infusion set was primed with water and, while priming the sets, one of the three infusion sets submitted, showed signs of leakage at the filter vent.A device history record review for model 2232-0007 lot number 21096282 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The sample was forwarded to the filter manufacturer for further investigation.Through investigation by the filter manufacturer, a root cause for the failure could not be determined.Based on the testing of the supplier, the hydrophobic vent membrane of the filter may have been compromised due to saturation by low surface tension end use solutions or potentially from the tube bonding solvents during set assembly.
Event or Problem Description
It was reported that 3 of the bd alaris¿ lvp gem v/nv 20d 0.2 fltr experienced leakage.The following information was provided by the initial reporter: leakage.

• Brand Name: BD ALARIS¿ LVP GEM V/NV 20D 0.2 FLTR
• 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 ; 8448235433
• MDR Report Key: 16709370
• Report Number: 9616066-2023-00654
• Device Sequence Number: 7454659
• Product Code: FPA
• UDI-Device Identifier: 50885403463967
• UDI-Public: (01)50885403463967
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 05/18/2023

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 Expiration Date: 09/29/2024
• Device Model Number: 2232-0007
• Device Catalogue Number: 2232-0007
• Device Lot Number: 21096282
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2021
• 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