MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE LINE; EXTENSION SETS/LINES

Model Number	MX458L
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510k is blank device is exempt.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 the six (6) inch y extension was leaking while in use with patient.No injury and no medical intervention was reported.The lines were re-primed, and extensions were replaced.The extension set was also noted to be cracked in subsequent nights.
Additional Manufacturer Narrative
Evaluation codes: updated.One (1) used decontaminated sample outside its original package and five (5) unused samples inside its original pouch were received.The used sample failed functional testing and all unused samples passed testing.The used sample was inspected under microscope to determine the cause of the leakage which was noted as a crack.The crack appeared in the knit line of the molded component which is considered the weakest portion of the port.All manufacturing tubing tapers are iso compliant.Taper used by customer cannot be confirmed as iso compliant.A root cause for the crack could not be determined.A device history record (dhr) review showed no discrepancies were observed during the manufacturing of the reported lot number.No action taken at this time as current controls are adequate for the complaint reported by customer.

• Brand Name: MEDEX EXTENSION SETS SINGLE LINE
• Common Device Name: EXTENSION SETS/LINES
• 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: 16639594
• Report Number: 3012307300-2023-03242
• Device Sequence Number: 14967723
• Product Code: FPK
• UDI-Device Identifier: 10351688507075
• UDI-Public: 10351688507075
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 05/10/2023

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: Health Professional
• Device Expiration Date: 03/07/2025
• Device Model Number: MX458L
• Device Catalogue Number: MX458L
• Device Lot Number: 4253911
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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 Age: 26 YR
• Patient Sex: Male