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

Model Number 537240PS

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Event problem and evaluation codes: updated.Initial reporter also sent report to fda? unknown.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.This remediation mdr was generated under (b)(4), as a result of warning letter cms# 617147.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.

Event Description

It was reported that when purging the equipment, the solution was not flowing through the infusion line.Change of line was performed.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
• Type of Device: 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: 16722271
• MDR Text Key: 313131670
• Report Number: 3012307300-2023-03949
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10351688516275
• UDI-Public: 10351688516275
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K831087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 853 KG
• Patient Ethnicity: Hispanic