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

Catalog Number 24-5404

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

We would like to inform you of the following issue: we were notified of a complaint from a customer stating that they received a pack of neuro sponges that contained 9 instead of 10.The sample was received and the reported concern has been confirmed.We want to ensure that you are aware of this issue and that we do require a response.Unfortunately, no lot number is available at this time.Based on when the pack was built we were able to determine the po number that the component originated from.If you would like the samples returned for investigation please provide a call tag.

Manufacturer Narrative

Upon completion of the investigation it was noted that the root cause is likely due to operator error.The patties are produced in a fully automated machine with very little human intervention.Patties which have been produced are inspected using a computer vision inspection throughout the process.The final step of the process is to place the patties on the card, which is done automatically by the machine.There is a vision system which then takes a picture of the 10 strings on the card and only allows it to pass if there were 10 strings found.The automated machine used to produce this product uses a vision inspection system to 'count' the number of patties on the card.The system is very robust at finding any missing patties.Therefore the most probable root cause lies in operator error.Automated pattie operators are trained not to rework any product to eliminate this risk of miscounts.A tcr could not be opened since the lot number was unknown.Another potential location could be at the packaging step, since operators will rewrap loose strings before packaging them product.Patties can become loose when the operators are handling the cards during packaging.A tcr could not be opened since the lot number was unknown.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 1/2
• Type of Device: PADDIE, 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: 5501542
• MDR Text Key: 40363477
• Report Number: 1226348-2016-10206
• 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

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 24-5404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• 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
• Patient Outcome(s): Required Intervention