MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE RADIOLOGY LP TRAY; CARDIAC CATHETERIZATION KIT

Model Number DYNDH1609

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  malfunction  

Event Description

Medline radiology lp tray dyndh1609, lot: 21dbx713 the extension tubing is manufactured incorrectly and leaks when either collecting cerebrospinal fluid or administering pharmaceutical.Fda safety report id# (b)(4).

• Brand Name: MEDLINE RADIOLOGY LP TRAY
• Type of Device: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 12134644
• MDR Text Key: 260575044
• Report Number: MW5102330
• Device Sequence Number: 1
• Product Code: OES
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: DYNDH1609
• Device Catalogue Number: DYNDH1609
• Device Lot Number: 21DBX713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1