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

Submit date: 04/08/2016.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 the customer had an issue with a: gauze sponge.The customer reported: they received shorted packs of comp# kc7148a.Two kits had packs of 9ea of this gauze, instead of the 10 ea that should be in each pk.This was reported on the plastic minor pack.Neither patient injury nor medical intervention has been reported.

Manufacturer Narrative

Submit date: 09/16/2016.There were 3 potential lot numbers reported for this complaint.Possible lots are: 15j196862x, 15k266562, 140001831962x.The device history record (dhr) for lot 15j196862x, 15k266562 and 140001831962x, there wer no defects found in 80 samples per inspected from each lot.There were no samples submitted with this complaint therefore the reported condition could not be confirmed.A possible root cause may be attributed to the scale challenge for weight count if it was not set up correctly on autobanders, added variables could have contributed to a weight discrepancy for the scale on the autobanders.Product originates from the manufacturing facility and then goes to another source to be used such as a kit packing facility.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.Counts are performed as part of the inspection criteria for in process.This evaluation is performed at a tightened sample size for miscounts.The lot met all defined acceptance requirements and was released.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 performed to tighten the bands.An additional capa has been opened to optimize the autobander process in which the product specification has been updated to include this complaint type and identify the occurrence.A rotation of stacked sponges will be removed from the process and validation activities will be performed.This capa is currently in the implementation stage.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 is currently being performed at a heighten level for products packaged using banded 10 units for miscount.This heightened testing is performed to ensure containment for the reported condition.An email was sent to the customer requesting sample availability or reason why one was not available on 04/08/16 & 09/14/16 & 09/16/16.

• 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: 5563455
• MDR Text Key: 42941863
• Report Number: 1018120-2016-00056
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• 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