MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE LINE INFUSION EXTENSIO; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number MX252L

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 09/28/2021

Event Type  malfunction  

Event Description

It was reported that the device connection came loose causing loss of medication and loss of iv access.No medical or surgical intervention was reported.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.

• Brand Name: MEDEX EXTENSION SETS SINGLE LINE INFUSION EXTENSIO
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• 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: 16580297
• MDR Text Key: 311683366
• Report Number: 3012307300-2023-02741
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688508232
• UDI-Public: 10351688508232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K782168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX252L
• Device Catalogue Number: MX252L
• Device Lot Number: 4161930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female