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

Catalog Number 80-1402

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Event Description

As reported by the ous affiliate, upon removal from its packaging on the surgical field, surgical patties were lacking the x-ray marker line.10 pieces out of 10 were normal, but the extra one, which was the 11th piece did not have the x-ray line and strings.It was only a piece of cotton.This incident was found when the staff counted the numbers of the devices.There might have been a possibility of intracorporal residual if they had not known there as the extra piece without any x-ray markers.The extra 11th piece has been already discarded.It was unknown if other packages have the extra pieces.They were used carefully in the surgery which concluded successfully.They were disposed of after the procedure.There were no reports of delay or patient harm.The product will not be returned.

• 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 (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8300780
• MDR Text Key: 134880659
• Report Number: 1226348-2019-10068
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• 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: HZ1255
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• 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