MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURG STRIP 1/4X6 PADDIE, COTTONOID

Catalog Number 80-1450

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4). Upon completion of the investigation it was noted that the sample was received and reviewed. Miscount of 9 strips was confirmed. Dhr reviewed and tcr opened. The manufacturing documentation was pulled and reviewed. Nothing was found to be out of the ordinary with this work order. Root cause of "miscount" is likely due to operator error, this however could not be determined. 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. A tr was opened to retrain all the operators that had worked on this product and lot #. 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. 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 the distributor, a 10-pack of codman surgical strips contained 9. There were no reports of delay or patient harm.

• Brand Name: CODMAN SURG STRIP 1/4X6
• 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: 7026308
• MDR Text Key: 247651391
• Report Number: 1226348-2017-10827
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 80-1450
• Device Lot Number: HA8252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/27/2017
• 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