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

Model Number	20028E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
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 bd alaris smartsite extension set had a leakage issue.The following information was provided by the initial reporter: ".The iv filter fluid leaking where tubing meets filter requiring new lines.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 14-mar-2022.D4: medical device lot #: 21129162 d4: medical device expiration date: 02-dec-2024 h4: device manufacture date: 02-dec-2021 h6: investigation summary the customer reported the tubing was leaking, and returned one sample of 20028e.The sample leaked from the filter connection, and the complaint is verified.The root cause for the filter connection is force applied to the joint, the plastic in the connection was damaged and cracked.The connection was broken completely apart without excessive force, and the inside of the connection revealed damage to the plastic.A device history record review for model 20028e lot number 21129162 was performed.The search showed that a total of 17,602 units in 1 lot number was built on 07dec2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported bd alaris smartsite extension set had a leakage issue.The following information was provided by the initial reporter: "the iv filter fluid leaking where tubing meets filter requiring new lines.".

• Brand Name: BD ALARIS SMARTSITE 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
• 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: 13761142
• Report Number: 9616066-2022-00229
• Device Sequence Number: 2369601
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 05/26/2022

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 Expiration Date: 12/02/2024
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: 21129162
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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