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

Catalog Number 24-5431

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the product was received and evaluated. The corrective action was to check the manufacturing documentation for this lot and perform a tcr with all the operators associated with this lot under question. The manufacturing documentation was 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 determined. 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 tcr was opened to retrain all the operators that had worked on this product and lot #. 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

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

Event Description

As reported by medline, a customer received a pack of surgical strips that had an incorrect amount. The 10 pack contained 12 strips. Event was noted during set up. Replacement product was used to complete procedure. No report of delay or patient harm.

• 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: 6979809
• MDR Text Key: 247570487
• Report Number: 1226348-2017-10791
• 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: distributor

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 24-5431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/13/2017
• 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