MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 4X4 NON ST 10S 16PLY; GAUZE SPONGE

Model Number 7148

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

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: there is an incorrect quantity.The pack contained nine instead of ten.

Manufacturer Narrative

Submit date: 08/30/2016.The device history record (dhr) for lot 15k266762 indicates that there were no defects were found in (b)(6) per machine inspected from the lot.There were no samples submitted with this complaint.The reported condition could not be confirmed.The complaint shall be reopened if a sample is received.A product analysis could not be performed as no samples were returned for this investigation.The exact root cause of the reported condition could not be determined without an actual sample to examine.A possible root cause may be attributed to the weight count if it was not set up correctly on the autobander.Added variables could have contributed to a weight failure for the scale on the autobanders.The product originates from the manufacturing site and then goes to another source to be used or processed.It is also possible that sponges could have been lost during that 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.Bundle counts are performed for miscounts per valid sampling plans on each lot produced.A formal corrective and preventative action (capa) was initiated to address the miscount complaints for vistec products.During this capa, the off line banding equipment was discontinued.A reversal of the autobander trays was adjusted to tighten the bands.The capa has been implemented to optimize the autobander process.A rotation of stacked sponges will be removed from the process and validation activities will be performed.This capa is currently in progress.This information will be utilized for trending purposes to determine the need for additional corrective actions.The production department will be notified of this incident with a copy of this complaint response.Finished goods testing are currently being performed at a heightened level for products packaged using banded 10 units for miscount.This heightened testing is performed to ensure containment for the reported condition.Two attempts were made to retrieve a sample.On (b)(6) 2016, the customer confirmed that the product would not be returned because it had been used.

• Brand Name: VISTEC SPG 4X4 NON ST 10S 16PLY
• 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 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5505403
• MDR Text Key: 40788915
• Report Number: 1018120-2016-00045
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 15K266762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1