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

Catalog Number	11088483
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd alaris¿ extension set leakage occurred when connected to microclave.The following information was provided by the initial reporter: xxx has experienced issues with leaks when connecting your product with a microclave.
Event or Problem Description
It was reported that during use with bd alaris¿ extension set leakage occurred when connected to microclave.The following information was provided by the initial reporter: xxx has experienced issues with leaks when connecting your product with a microclave.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of leakage when connecting to a microclave could not be verified due to the product not being returned for failure investigation.The bd luer in question complies with iso-594.Competitor luers should also be in compliance with this standard, and there should not be any issues with connection based on dimensions.A sample analysis would help to identify the problem.A device history record review could not be performed on material 11088483 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• 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 ; 8448235433
• MDR Report Key: 17337885
• Report Number: 9616066-2023-01469
• Device Sequence Number: 17974775
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/03/2023

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 Catalogue Number: 11088483
• Device Lot Number: UNKNOWN
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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