MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. X-RAY DETECT LAP SPONGE 4PLY 18X18; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	MDS251518LF
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medline lap sponges opened for ep (electrophysiology) procedure table, upon inspection by staff there was a cluster of dust processed with the laps.The laps were thrown off and ensured no table or sterile employee contaminated.Barcode on laps was (b)(4), ref #mds251518lf, 18x18 sponges.These sponges were not used in patient case and discarded.

• Brand Name: X-RAY DETECT LAP SPONGE 4PLY 18X18
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 17370211
• Report Number: 17370211
• Device Sequence Number: 15212756
• Product Code: GDY
• UDI-Device Identifier: 10080196743926
• UDI-Public: (01)10080196743926
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/14/2023
• Report Date (Section F): 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MDS251518LF
• Device Lot Number: 8052303011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/14/2023