MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. REPLACEMENT LINES FOR IRRIGATION FLUID WARMING LEV; WARMER, THERMAL, INFUSION FLUID

Model Number	PL-6
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the female connectors were placed on both sides of the patient line set; this made the set unusable.This was noted on 11 pieces.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The returned samples consisted of twelve (12) products; ten (10) products were received in new conditions with their original unopened packaging and two (2) gas vent assemblies were received in used conditions.Visual inspection: the samples were visually inspected at a distance of 12 inches to 24 inches under normal conditions of illumination; eleven (11) samples had assembled two (2) female connectors instead of one (1) female connector and one (1) male connector in the gas vent assembly.The most probable root cause of the issue were: the gas vent assembly was not properly assembled by the operator; the assemblies with the wrong components were not detected through the in-process inspection.Action(s) taken to mitigate the reported issue(s): production personnel was retrained by the production supervisor in order to reinforce the assembly operation of the gas vent assembly and to reinforce the in-process inspection to verify for correct components.

• Brand Name: REPLACEMENT LINES FOR IRRIGATION FLUID WARMING LEV
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15656525
• Report Number: 3012307300-2022-25966
• Device Sequence Number: 14961627
• Product Code: LGZ
• UDI-Device Identifier: 30695085460200
• UDI-Public: 30695085460200
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K072080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2022

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: 05/10/2022
• Device Model Number: PL-6
• Device Catalogue Number: PL-6
• Device Lot Number: 3631759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown