MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX MICRO BORE EXTENSION SET, 60 INCH, 0.22 MICRON FILTER; FILTER, INFUSION LINE

Catalog Number	FS116
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - other: device has not been returned to date.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 the filter.Tubing replaced.There was patient involvement.The medical intervention required was an iv tubing change after discovery of the leak.The outcome of the event was resolved.
Additional Manufacturer Narrative
Investigation summary: the affected devices were received for evaluation.The two (2) returned samples were visually inspected under microscope to determine the cause of the leakage.It was observed that the two (2) parts exhibited lack of solvent between the bonding union of the tube.A water leak test was conducted and exhibited a leak.Both of the samples were tested in a pull test and found the samples to be acceptable.Both samples tubing were measured using micro-vu and were found within specifications.The customer's indicated failure was duplicated and confirmed through functional testing.The root cause was identified to be the lack of solvent between the bonding union of tube.A device history record could not be completed as no lot number was received.As a result, no action was taken due to the condition of the device.It was deemed to be beyond economical repair and will be scrapped.

• Brand Name: MEDEX MICRO BORE EXTENSION SET, 60 INCH, 0.22 MICRON FILTER
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19127861
• Report Number: 1526863-2024-00027
• Device Sequence Number: 12672918
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: FS116
• Device Lot Number: 4440746
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 07/15/2024
• 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
• Patient Age: 11 YR
• Patient Sex: Unknown
• Patient Weight: 27 KG