MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC GAUZE 4X4 IN RETROGRADE PACK; GUAZE

Catalog Number DYNJ47873B

Device Problem Material Frayed (1262)

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

Event Date 06/22/2016

Event Type  malfunction  

Event Description

Unsafe condition.The gauze 4x4's in our retrograde packs frequently have fraying edges and "flake" off little bits of thread.Staff report that this has been an ongoing issue.Staff are replacing the gauze on the tray with gauze from a different source.We have contacted the medline representatives and action is pending.

• Brand Name: GAUZE 4X4 IN RETROGRADE PACK
• Type of Device: GUAZE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein, IL 60060
• MDR Report Key: 5761045
• MDR Text Key: 48558723
• Report Number: 5761045
• Device Sequence Number: 0
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2016,06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ47873B
• Device Lot Number: 160B4372
• Other Device ID Number: 22025203
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1