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

Catalog Number	20043E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 medication leaked between the bd alaris¿ smartsite¿ extension set and icu medical microclave connector during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "leaking drug between the connection of the bd smartsite extension set and the icu medical microclave connector.Did you experience any adverse events as a result of the reported failure?- no".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of leaking between bd smartsite and icu microclave could not be verified due to the product not being returned for failure investigation.Device history record review for model 20043e lot number 22095286 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
It was reported that medication leaked between the bd alaris¿ smartsite¿ extension set and icu medical microclave connector during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "leaking drug between the connection of the bd smartsite extension set and the icu medical microclave connector.Did you experience any adverse events as a result of the reported failure?- no".

• 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: 15973597
• Report Number: 9616066-2022-01950
• Device Sequence Number: 6997861
• Product Code: FPA
• UDI-Device Identifier: 50885403234871
• UDI-Public: 10885403234873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/25/2023

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: 09/14/2025
• Device Catalogue Number: 20043E
• Device Lot Number: 22095286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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