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

Model Number	10839681
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter facility name: (b)(6) hospital.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris extension set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking from extension set: where on the extension set was the leakage? the staff isn¿t aware of exactly where it was leaking from.Did this happen with multiples units from a lot? the staff didn¿t keep the lot #.Did this happen with multiple placers/clinicians? this has now happened multiple times on two different units.Was there any harm to patient(s)? we are not aware of any permanent harm, but the patient had at a minimum, temporary discomfort.Additional medications were needed due to the leakage.
Event or Problem Description
It was reported while using bd alaris extension set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking from extension set where on the extension set was the leakage? the staff isn¿t aware of exactly where it was leaking from.Did this happen with multiples units from a lot? the staff didn¿t keep the lot #.Did this happen with multiple placers/clinicians? this has now happened multiple times on two different units.Was there any harm to patient(s)? we are not aware of any permanent harm, but the patient had at a minimum, temporary discomfort.Additional medications were needed due to the leakage.
Additional Manufacturer Narrative
Investigation summary: the customer reported the extension set was leaking, and returned one photo of the incident.The photo verifies the separation at the outlet tubing to trifuse hub.The root cause of the incident could not be determined without the sample for investigation.A device history record review could not be performed on material (b)(4) because the lot number is unknown.

• 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: 17056631
• Report Number: 9616066-2023-01075
• Device Sequence Number: 5178124
• Product Code: FPA
• UDI-Device Identifier: 50885403234536
• UDI-Public: (01)50885403234536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/13/2023

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 Model Number: 10839681
• Device Catalogue Number: 10839681
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/01/2023
• 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