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

Catalog Number 24-5431

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2014

Event Type  Injury  

Event Description

The customer stated: one pack of the 1/4" neuro sponges only contained 9 sponges instead of 10.Customer stated sample is pending.Will forward upon receipt.

Manufacturer Narrative

Upon completion of investigation, a follow up report will be filed.

Manufacturer Narrative

A kaizen project has been kicked off to analyze our current process and to eliminate the opportunity of miscounting product.This project will evaluate the risk of creating a miscounts and improve the process by implementing solutions that will reduce our complaints.It was determined that the operator must have miscounted the strips and due to the weight variation of a missing strip being so small the count scale must have accidentally counted the appropriate amount.A retraining was done with the operators that worked on this lot of material (tcr #(b)(4)) to bring operator awareness to the issue.Root cause is likely due to operator error.Per the requirements of the specification the operator is required to count the amount of surgical strips and weigh the package with the strips to verify the count prior to sealing them in the package.A retraining was done with the operators that worked on this lot of material (tcr #(b)(4)) to bring operator awareness to the issue.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Complaint sample not returned.

• Brand Name: BULK SURG STRIP 1/4 X 6
• Type of Device: COTTONOID PADDIE
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3841421
• MDR Text Key: 22003597
• Report Number: 1226348-2014-11694
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• 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: 482971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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