MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. 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 09/29/2014

Event Type  Injury  

Event Description

The customer stated: one package of the sponge neuro inside the neuro craniotomy pack only contained 9 sponges instead of 10.There was no injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

This complaint has been re-opened as the device was returned for investigation.It was noted that in an attempt to reduce these types of complaint a new packaging machine has been installed, which reduces this risk of this type of complaint.The main issue we found was that the operator couldn't verify that the package was filled completely with the product before the package was sealed.The new packaging machine allows the operator to load the bag while the bag is being sealed and the operator can check the package to make sure the bag has all the appropriate components in it.Training was conducted with the operators that produced this lot number to make them aware of the issue.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.

Manufacturer Narrative

The customer was contacted regarding product returned; however, product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.This is the first complaint of this type for this product code and lot number.We will continue to monitor for this or similar complaints for this product code.A review of the device history records revealed that this lot met specification during manufacturing processes.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.

• Brand Name: BULK SURG STRIP 1/4 X 6
• Type of Device: COTTONOID PADDIE
• 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: 4141502
• MDR Text Key: 4934168
• Report Number: 1226348-2014-12026
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2014
• 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: 518329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2014
• 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