MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE LAPAROTOMY SPONGES; GAUZE/SPONGE, INTERNAL

Catalog Number DYNJ49652B

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 02/28/2020

Event Type  malfunction  

Event Description

Performing the initial surgical count prior to the patient entering the room.Unbanding, separating and counting the laparotomy sponges it was noted the four lap sponges were banded.A verification count was performed and was confirmed incorrect number of lap sponges present.The were removed from the field.This was from the plastics major pack.

• Brand Name: MEDLINE LAPAROTOMY SPONGES
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9910187
• MDR Text Key: 185943163
• Report Number: 9910187
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJ49652B
• Device Lot Number: 19KMC682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1