MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 1/2 X 1; PATTIE, COTTONOID

Catalog Number 24-5406

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

We were notified of a complaint from a customer stating that the one of the neuro sponges was stained with a large brown spot.The sample was received and the reported concern has been confirmed.The large brown stain was found on the back of the neuro sponges and is.5 inch in diameter.We want to ensure that you are aware of this issue and that we do require a response.On (b)(6) 2016 per distributor: "the defect was found during set up and did not delay the procedure more than 30 minutes.The patient was not affect by the incident as they pulled sterile product from their inventory.Unfortunately, i was not able to obtain a lot number as this component is not lot tracked within our system.".

Manufacturer Narrative

Upon completion of the investigation, it was noted that a light brown 'spot' (approx.25" in diameter) was on the top pattie in the pack, directly around/below the area of the green string.The spot was produced when the string was welded to the cottonoid material.The cottonoid is formed from a rayon material.During processing this rayon material is broken down into small, loose fibers.If the fibers do not break down enough, a small cluster of fibers can result.This in turn creates a thick spot in the pattie.When the string is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Root cause is likely due to operator error.Per the requirements of the specification the operator is required to inspect the front and back of the patties for any imperfections such as burn marks and also count the amount of surgical patties.A tr and course were opened to retrain all the operators that produce product on hybrid machines since a lot number was not returned with the complaint.Based on the results of this investigation, no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: BULK SURG PAT 1/2 X 1
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5616223
• MDR Text Key: 43995431
• Report Number: 1226348-2016-10326
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: Health Professional
• Device Catalogue Number: 24-5406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1