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

Catalog Number CMP J08203B

Device Problem Component Missing (2306)

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

Event Date 02/20/2020

Event Type  malfunction  

Event Description

Minor laparotomy pack was missing the yankauer suction from the pack, although the itemized list shows there should be a quantity of 1 in the pack.Fda safety report id# (b)(4).

• Brand Name: YANKAUER IN MINOR LAPAROTOMY PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 9753881
• MDR Text Key: 181528711
• Report Number: MW5093288
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CMP J08203B
• Device Lot Number: 19HBC645
• Was Device Available for Evaluation?: No
• 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