MAUDE Adverse Event Report: RAYNHAM C AND T SET FLYING LEADS RP BULK; DISPOSABLE CODMAN CORD AND TUBING

Catalog Number 9190002RPB

Device Problem Biofilm coating in Device (1062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a bipolar cord (id 9190002rpb) with a green substance.It was noticed during setup, prior to procedure.No surgical delay.

Manufacturer Narrative

The disposable codman cord and tubing (id 9190002rpb) has been returned for evaluation.Unique device identification (udi) - (b)(4).Failure analysis - it was determined that green residue was present on the returned material.Samples were sent to an integra testing laboratory and a material analysis was performed.It was determined that the green substance is likely to be pvc plasticizer leaching from the material.This is thought to occur in the presence of adverse heat conditions and over time.Root cause - the complaint was confirmed in the complaint investigation.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.Per the failure analysis, the root cause is likely due to adverse heat conditions and/or aging components.

• Brand Name: C AND T SET FLYING LEADS RP BULK
• Type of Device: DISPOSABLE CODMAN CORD AND TUBING
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16062938
• MDR Text Key: 307789585
• Report Number: 3014334038-2022-00291
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K163106
• 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,Followup
• Report Date: 07/12/2023

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: 9190002RPB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/12/2023
• 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: Unknown
• Patient Sequence Number: 1