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

Model Number	30914
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ extension set experienced a loose iv set connection.The following information was provided by the initial reporter: defective luer-lok connection that doesn¿t create a secure connection and allows air to enter the line.We have had to switch to using all microbore with the pressure-sensing disc until we can try a new lot #.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-dec-2022.H6: investigation summary one sample was received for quality investigation.The customer complaint of connection issues 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 capped and pressure was applied to the syringe to increase the pressure on the extension set and examine if the male luer connector allowed for any leakage.The male luer operated as intended and did not leak.A device history record review for model 30914 lot number 22093247 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16aug2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue reported could not be determined because the reported failure could not be replicated.H3.
Event or Problem Description
It was reported that the bd alaris¿ extension set experienced a loose iv set connection.The following information was provided by the initial reporter: defective luer-lok connection that doesn¿t create a secure connection and allows air to enter the line.We have had to switch to using all microbore with the pressure-sensing disc until we can try a new lot #.

• 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: 15964034
• Report Number: 9616066-2022-01938
• Device Sequence Number: 14687096
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• 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 Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 22089342
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/25/2023
• 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