MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE LINE; TUBING, FLUID DELIVERY

Model Number	MX451FL
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Dhr: a review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
Event or Problem Description
It was reported that the extension tubing used that goes at the end of the tpn and lipid set up, snapped off from picc cap.The connecting piece on the tubing was still attached to the picc cap, and the tubing itself became detached.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: no product was returned for investigation.However, a maintenance work order history was reviewed during and around the time that the lot reported was manufactured.Lot 4098130 was produced between 03-feb-2021 and 05-feb-2021; during this production run, two work orders were written.Wo-0000528506 was written with a description that indicated that no solvent was being applied to the tubing on the male end of the set on (b)(6) 2021 1st shift.The root cause was found to be that the drop needle that applies the solvent had bent enough that intermittent tubing sets were not receiving the solvent.The correction was to replace the bent needle.Wo-000528599 was written with a description that also indicated that no solvent was being applied to the tubing on the male end of the tubing set on (b)(6) 2021 2nd shift.The root cause was that the bolt that controls the drop needle adjustment was loose and allowed the needle to move.The correction was to place the needle back and tighten the bolt., corrected data: updated the additional manufacturer narrative.
Additional Manufacturer Narrative
Other text: corrected data: b1, corrected data: corrected data: b1 product problem.

• Brand Name: MEDEX EXTENSION SETS SINGLE LINE
• Common Device Name: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 750; minneapolis, MN 55442
• MDR Report Key: 13527458
• Report Number: 3012307300-2022-03337
• Device Sequence Number: 4073098
• Product Code: FPK
• UDI-Device Identifier: 10351688507310
• UDI-Public: 10351688507310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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: 01/31/2024
• Device Model Number: MX451FL
• Device Catalogue Number: MX451FL
• Device Lot Number: 4098130
• Was Device Available for Evaluation?: No
• 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: 04/15/2021
• Supplement Date Received by Manufacturer: 02/14/2022; 06/15/2023
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/17/2022; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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