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

Catalog Number MDS251504LF

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

Incorrect number of sponges in medline x-ray detectable gauze sponges pack.Baby laps ref # mds251504lf lot #26019070011 (packaging sent to central) issue: only 4 baby laps found upon opening/should be 5 xray detectable gauze sponges ref #non21430lf lot #6051901085 (will send packaging to risk) only 9 sponges found/should be 10.

• Brand Name: LAP SPONGES
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9818618
• MDR Text Key: 182962118
• Report Number: 9818618
• 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: 02/11/2020,10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS251504LF
• Device Lot Number: 26019070011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Date Report to Manufacturer: 03/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1