MAUDE Adverse Event Report: COVIDIEN G0X0X-0XP0XC(N)-1 GAUZE ¿ RF AND X-RAY DETECTABLE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number G0404-16P01C-1

Device Problems Material Fragmentation (1261); Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 08/24/2018

Event Type  malfunction  

Event Description

The gauze is very loosely put together and threads are subject to detach.Affected lot #'s.Company: (b)(4).Location: (b)(4).Item: gauze 4x4 16 ply rfd.Description: active.Status: yes.Tracked manuf-nbr: (b)(4).Manufacturer response for medtroinc rfid gauze, (brand not provided) (per site reporter).Suggest trying the 24-ply if this is an ongoing problem.I apologize.We only have 4x4 in 16 and 32 ply.I honestly think you will find 32 ply to be too thick.Let me know if you would like those codes & pricing.Otherwise i would suggest that we just submit a quality complaint.

• Brand Name: G0X0X-0XP0XC(N)-1 GAUZE ¿ RF AND X-RAY DETECTABLE
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7881421
• MDR Text Key: 120553691
• Report Number: 7881421
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: G0404-16P01C-1
• Device Catalogue Number: G0404-16P01C-1
• Device Lot Number: 171121A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1