MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE LINE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	537240PS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.Event problem and evaluation codes: updated.Device evaluation: two sample was returned for investigation.The samples were received in used condition without the original package.Returned samples were tested for water leak; returned samples exhibited occlusion condition.The samples were also visually inspected under a microscope to detect the cause of obstruction.It was observed that the internal diameter of the tube was obstructed.The occlusion condition found on returned samples is related to a supplier issue.An awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held.Device history record (dhr) was performed, and no issues or deviations were observed during the manufacturing of this lot.An internal scar has been opened and this issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported by nephrology service that when priming the line with physiological solution an obstruction was identified.Change of equipment was needed.The samples were not in touch with the patients.The medical staff noticed the obstruction while purging and preparing the equipment.No patient injury reported.

• Brand Name: MEDEX EXTENSION SETS SINGLE LINE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 16722274
• Report Number: 3012307300-2023-03951
• Device Sequence Number: 7967129
• Product Code: FPA
• UDI-Device Identifier: 10351688516275
• UDI-Public: 10351688516275
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K831087
• 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
• Report Date (Section B): 04/11/2023

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: 04/19/2024
• Device Model Number: 537240PS
• Device Catalogue Number: 537240PS
• Device Lot Number: 4138665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• 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: 03/28/2022
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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 Age: 10 YR
• Patient Sex: Female
• Patient Weight: 27 KG
• Patient Ethnicity: Hispanic