MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS MULTI LINE WITH FILTER; FILTER, INFUSION LINE

Model Number	FS116
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3: date of event is unknown, no information has been provided 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 required.
Event or Problem Description
It was reported that the bond between the tubing and the in line filter was defective resulting in leaking from the line.Patient involvement is unknown.
Event or Problem Description
Additional information was received confirming the event was discovered while in use with a patient, the outcome was resolved, no patient harm occurred, and no medical intervention was needed.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection found a lack of solvent was observed on the bonding of the tube.Functional testing confirmed the complaint when a leak was detected.The root cause was attributed to an incorrect solvent application during the bonding process.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.No escalation was required as the current controls are adequate.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE WITH FILTER
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17157894
• Report Number: 3012307300-2023-06287
• Device Sequence Number: 14957791
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: 10351688510969
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 07/25/2025
• Device Model Number: FS116
• Device Catalogue Number: FS116
• Device Lot Number: 4304829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown