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

Catalog Number	C42014E-07
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 during use with bd alaris¿ smartsite¿ gravity set the tubing broke off at the port.This is 2 of 2 malfunctions.The following information was provided by the initial reporter: it was reported by the customer that complaint involving bd smart site gravity tubing breaking off at the port.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 07-jul-2023.H6: investigation summary one sample of material number c42014e-07 was received for quality investigation.The customer complaint of component damage- no leak was not verified by inspection, however, after inspection of the sample, separation of the tubing was identified.The received sample was visually inspected for any visible damages to the components.There were no damages located to the components, however, the tubing had separated from a y-site smartsite inlet port in the assembly.Further examination of the separation location indicates that the amount of solvent visible on the y-site smartsite inlet port and the tubing is not sufficient to maintain the bond between the two components.A device history record review for model c42014e-07 lot number 22089046 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The failure seen in this complaint is the lack of solvent between the y-site inlet port and tubing.After an investigation at the manufacturing facility, the root cause for the failure was determined to be a partial insertion of the components by the operator.This indicates that the operator did not follow the insertion method established in the assembly procedure.
Event or Problem Description
It was reported that during use with bd alaris¿ smartsite¿ gravity set the tubing broke off at the port.This is 2 of 2 malfunctions.The following information was provided by the initial reporter: it was reported by the customer that complaint involving bd smart site gravity tubing breaking off at the port.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17234712
• Report Number: 9616066-2023-01333
• Device Sequence Number: 20716908
• Product Code: FPA
• UDI-Device Identifier: 07613203020756
• UDI-Public: (01)07613203020756
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 10/05/2023

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: 08/03/2025
• Device Catalogue Number: C42014E-07
• Device Lot Number: 22089046
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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