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

Catalog Number	30914
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda notified?: the initial reporter also notified the fda via medwatch # mw(b)(4).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 the bd alaris¿ extension set had a loose connection and allowed air to enter the line during use.The following information was provided by the initial reporter: "luer lock end of extension tubing defective.Would not tighten to form a closed system.Allowed air to enter line.".
Additional Manufacturer Narrative
H6: investigation summary one sample was received for quality investigation.The customer complaint of luer fittings incompatible - air bubbles / air in line could not be verified by investigation.The investigation began with a visual inspection of the extensions set for any damage or broken components.No damage was visually apparent.The extension set was then primed using a syringe with water.The distal male luer was connected to another sample extension set to check if there was any air in line or leakage from the male luer connection site.Pressure was applied to the syringe, to increase the pressure on the assembly, and examined if the male luer connector allowed for any leakage, air in line, or air bubbles.The male luer operated as intended.A device history record review for model 30914 lot number 22093247 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for the issue reported could not be determined because the failure could not be replicated.
Event or Problem Description
It was reported that the bd alaris¿ extension set had a loose connection and allowed air to enter the line during use.The following information was provided by the initial reporter: "luer lock end of extension tubing defective.Would not tighten to form a closed system.Allowed air to enter line.".

• Brand Name: BD ALARIS¿ 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: 16016685
• Report Number: 9616066-2022-02005
• Device Sequence Number: 14894847
• Product Code: FPA
• UDI-Device Identifier: 10885403233319
• UDI-Public: 10885403233319
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 01/09/2023

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: 08/16/2025
• Device Catalogue Number: 30914
• Device Lot Number: 22089342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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