MAUDE Adverse Event Report: COVIDIEN XPRT 8X8 AMD FOAM DRSG; FOAM DRESSING

Model Number 55588AMDX

Device Problem Particulates (1451)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/16/2015.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a foam dressing.Customer reports: amd foam stuck to wound and particles of foam remain in wound.

Manufacturer Narrative

The actual complaint sample was returned for review by the customer.The customer returned 3 unopened samples of product code 55588amdx, lot# 140001057262x.In addition, 2 photos of the reported condition were also submitted with the complaint.The photos were evaluated for the reported condition and clearly showed small pieces (~2mm according to the scale in the picture) attached to the wound once the dressing had been removed.The returned samples showed no abnormalities visually (i.E.Color, texture).The samples were submitted for testing according to product specification for color, appearance, absorptive capacity, softness, and phmb concentration.The device history record (dhr) was reviewed for lot # 140001057262x and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.All test results were within specification.The research & development (r&d) team was also consulted to see if there were any contra indications of foam with other materials that would cause the degradation in any way of the foam.R&d was not aware of any identified risk of this nature associated with this product.Operators were consulted to determine if any sticking property of the foam had ever been noted in the manufacturing process, but nothing of this nature had been seen.The notes section mentioned that the dressing was changed at 48 hours, well within the recommended timeframe of 7 days per the instructions for use (ifu).A possible root cause is that the foam interacted with a topical treatment used during the adjuvant therapy for chronical venous insufficiency that had an effect not currently known to exist.This issue will be reviewed during the monthly report out for the factory.No changes to the quality control sampling plans are deemed necessary.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.No formal corrective action preventive action has been created for this complaint.This complaint will be used for trending purposes and reviewed with plant management.

• Brand Name: XPRT 8X8 AMD FOAM DRSG
• Type of Device: FOAM DRESSING
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30913
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5226405
• MDR Text Key: 31522196
• Report Number: 1018120-2015-00034
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 55588AMDX
• Device Catalogue Number: 55588AMDX
• Device Lot Number: 140001057262X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1