MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE; PATTIE, COTTONOID

Catalog Number 80-1402

Device Problems Component Missing (2306); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the operation room staff found that quantity of the product was not as expected.There were 11 pieces inside of the brand new package.This was detected on (b)(6) 2017.Also, it was reported that one of the patties did not have x-ray impermeable line on the product.There was no surgical delay and no adverse consequences to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Device was returned for investigation.Upon completion of the investigation a follow up report will be filed.

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 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 determined.Per the requirements of the specification the operator is required to inspect the front and back of the patties and also count the amount of surgical patties.Operators are trained to wrap each string onto a counting card to make it very visible and to confirm that there are only 10 surgical patties on the card.A ilc 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.

• Brand Name: CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE
• Type of Device: PATTIE, 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: 6476207
• MDR Text Key: 72509615
• Report Number: 1226348-2017-10243
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1402
• Device Lot Number: H25942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/11/2017; 05/23/2017
• 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
• Patient Sequence Number: 1