MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6; PADDIE, COTTONOID

Catalog Number 24-5431

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

There were 9 of the neuro sponge 1/4x6 inch, 24-5431 in the pack instead of 10.

Manufacturer Narrative

Upon completion of the investigation it was noted that the corrective action was to check the manufacturing documentation for this lot and perform a tcr for all the operators associated with the lot under question.The manufacturing documentation for lots c58961 and 751552 was pulled and reviewed.Nothing was found to be out of the ordinary with this work order.Root cause is likely due to operator error, this however could not be confirmed.Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack.The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack.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 STRIP 1/4 X 6
• 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: 6095673
• MDR Text Key: 59717360
• Report Number: 1226348-2016-10783
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880402
• 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: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 24-5431
• Device Lot Number: C58961, 751552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• 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