MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE LINE; STOPCOCK, I.V. SET

Model Number MX252L

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/28/2021

Event Type  malfunction  

Event Description

It was reported that the connection was found loose between the stopcock and intravenous (iv).The iv was removed and secondary iv started in other extremity using the same equipment.Magnetic resonance imaging (mri) staff reported that a similar event occurred from the first scan.The connection came loose, causing loss of medication and loss of iv access.No patient injury was reported.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.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.

• Brand Name: MEDEX EXTENSION SETS SINGLE LINE
• Type of Device: STOPCOCK, I.V. SET
• 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: 16787487
• MDR Text Key: 313761652
• Report Number: 3012307300-2023-04369
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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
• Date Device Manufactured: 08/20/2021
• 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