MAUDE Adverse Event Report: COVIDIEN SPNG,GAUZE,4 IN X 4 IN,16 PLY,; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the sponges fell apart during normal use during the procedure.The ends frayed and the radiopaque marker became dislodges.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.17m145062 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.All device history records (dhrs) are reviewed by the shift manager and quality assurance prior to release.Inspectors routinely examine a statistical sample both physically and visually.For sterilized products, the dhr and the sterilization documents undergo further review prior to release to the distribution center.No issues were found during the inspections.There were no manufacturing issues related to the complaint issued for this lot.A photograph sample was provided for evaluation.Visual review of the photograph was unable to make a confirmed analysis of the product.It was observed that the sponge in the photograph was unfolded, which is contrary from the form of suggested use.Without a physical sample, a comprehensive investigation was unable to be conducted.The reported customer complaint is unable to be confirmed.A root cause could not be determined.Notifications to employees involved in the production of this product were provided to heighten awareness and to alert for any type of contamination.This complaint will be utilized for tracking and trending purposes.

• Brand Name: SPNG,GAUZE,4 IN X 4 IN,16 PLY,
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 8325012
• MDR Text Key: 135689534
• Report Number: 1018120-2019-00335
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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 Operator: No Information
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 17M145062
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1