MAUDE Adverse Event Report: NULL MEDEX STOPCOCKS; STOPCOCK, I.V. SET

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Udi, device serial number/lot number, catalog number are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the patient turned and then monitored with 1:1 nursing for 1 hour with no clinical changes noted and no changes to patient's infusing iv lines.When bedside nurse returned 30 minutes later, the stopcock was found to have spontaneously unthreaded and the patient's sedation infusions were not infusing into patient.

Manufacturer Narrative

Other text: h6 - evaluation codes: updated.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number was provided so a device history report (dhr) review could not be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation., corrected data: h6 - health effects codes.

• Brand Name: MEDEX STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section G): NULL
• MDR Report Key: 15843230
• MDR Text Key: 307685098
• Report Number: 3012307300-2022-27396
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1