MAUDE Adverse Event Report: COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7317

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 09/17/2019

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

The customer reported that a pack of x-ray detectable sponges only had 9, and expected quantity is 10.

Manufacturer Narrative

A device history record review was completed for the reported lot number.There were no manufacturing problems related to the complaint issued for this lot.There were no physical samples received with this complaint therefore an examination of the reported issue could not be made.If additional information or samples are received, the investigation will resume as needed.Trending had been done with customer complaints and it was found that a corrective and preventative action (capa) was required.The lot number provided is within the scope of the corrective action plan.The formal investigation was opened due to complaints reported for vistec miscounts.The formal investigation is in the effectiveness stage.This complaint will be used for trending purposes.

• Brand Name: 7317 SPG VISTEC 4X4 STR 10'S
• 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: 9088433
• MDR Text Key: 159513927
• Report Number: 1018120-2019-00378
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 18J126462
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2019
• Patient Sequence Number: 1