MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MINOR PACK; LAPAROSCOPY KIT

Model Number DYNJ49355

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

As the medline industries, minor pack was opened and the bulb syringe was removed from the styrofoam tray, it was noted that there was a significant amount of residual foam on the bulb of the hub syringe.This device was removed from the field and replaced.Fda safety report (b)(4).

• Brand Name: MINOR PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 8509198
• MDR Text Key: 141935049
• Report Number: MW5085816
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: DYNJ49355
• Device Catalogue Number: DYNJ49355
• Device Lot Number: 18LBK715
• 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