MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX IV FILTER EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	FS116
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Fever (1858); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Date of Event	03/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that one set of pediatric filtered tubing was leaking out around filter.Tubing replaced.The medical intervention required iv tubing was changed after discovery of leak.Patient was not tachycardic, hypertensive, tachypneic and developed a low-grade fever (37.6c) and was very restless.Found the leak and determined the patient had been leaking dexmedetomidine out of his line for around 4 hours before discovery.The outcome of the event was resolved.
Additional Manufacturer Narrative
D9.Date returned to manufacturing -4/1/2024.H6.Investigation codes: updated.Two devices were returned for evaluatio.Vi.Sual inspection was performed, and it was observed that the two parts exhibited lack of solvent between the bonding union of the tube and filter.Functional testing was performed, and it was observed that the two samples leaked between the bonding union of tube and filter.Pull test and tubing measurements were acceptable.The customer¿s reported problem was confirmed.The most probable cause of the condition identified is related to lack of solvent the between the bonding union of tube and filter.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.A capa was initiated to investigate root cause.
Additional Manufacturer Narrative
B1, b2, h1 and h2 - updated.

• Brand Name: MEDEX IV FILTER EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19133525
• Report Number: 9616567-2024-00064
• Device Sequence Number: 4720608
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: (01)10351688510969(17)261128(10)4440746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FS116
• Device Lot Number: 4440746
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 09/12/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/16/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEXMEDETOMIDINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 DA
• Patient Sex: Unknown
• Patient Weight: 252 KG