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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
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 the bd alaris¿ extension set luer-lok cap broke off.The following information was provided by the initial reporter: "i just received another sample with the luer cap broken away from the end.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 04-jan-2023.H6: investigation summary one sample of the extension set 30914 was submitted for quality investigation.The customer complaint could not be verified by visual inspection.Visual inspection of the sample was conducted with no damages or defects were found.The set was then connected to a sample smartsite and primed with water.The smartsite end was capped and the sample pressurized hydrostatically do determine if liquid is leaking from the connectors and tubing.There was no leakage, air-in-line or occlusions found during testing.Additionally, the luer design was compared with the engineering construction drawings and there were no differences to found.A device history record review for model 30914 lot number 22089342 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 could not be determined as the failure could not be replicated.
Event or Problem Description
It was reported that the bd alaris¿ extension set luer-lok cap broke off.The following information was provided by the initial reporter: "i just received another sample with the luer cap broken away from the end.".

• 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: 16134806
• Report Number: 9616066-2022-02185
• Device Sequence Number: 6704055
• 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): 02/08/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/28/2023
• 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