MAUDE Adverse Event Report: COVIDIEN RONDIC ROUND GZ XR SPG LG NONST; GAUZE SPONGE

Model Number 6591

Device Problems Material Frayed (1262); Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 07/07/2016.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze sponge.The customer reports: gauze is frayed and the packaged is not sealed.

Manufacturer Narrative

There were 19 samples unused, opened returned with this complaint received for evaluation.After a visual inspection, the sponges have frayed gauze and the reported condition is confirmed.The returned product did not meet quality release specifications.The most likely root cause is untucked edges due to off-center gauze when pushed into the cylinder during the manufacturing process.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, operators inspect for raw edges and fraying during the manufacture of sponge.The operator also confirms gauze alignment during setup and machine operation.The lot met all defined acceptance requirements and was released.The returned product would not meet quality control release specifications in its current condition.This information will be utilized for trending purposes to determine the need for corrective actions.A quality notice was posted at the quality spotlight board in the main hallway of the plant to raise awareness of this issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RONDIC ROUND GZ XR SPG LG NONST
• Type of Device: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5775070
• MDR Text Key: 49674117
• Report Number: 1018120-2016-00097
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6591
• Device Catalogue Number: 6591
• Device Lot Number: 15M058562
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1