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

Model Number	9190002GF
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A facility reported a green residue in the bipolar cord and tubing (id (b)(4)).It was discovered during a stock check of inventory to be used in kits.The product has been placed on hold to prevent being placed in kits.No patient injury reported and the event did not led to surgical delay.
Additional Manufacturer Narrative
Disposable codman cord and tubing were returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the reported complaint was confirmed via investigation; green residue was found on the returned cord and tube sets.Root cause - the root cause is being investigated; however, currently the complaint issue does not represent an adverse trend.The issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.

• Brand Name: C AND T SET FLYING LEADS GF
• Common Device Name: 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: 15469973
• Report Number: 3014334038-2022-00212
• Device Sequence Number: 17260319
• Product Code: GEI
• UDI-Device Identifier: 10381780521754
• UDI-Public: 10381780521754
• Combination Product (Y/N): N
• PMA/510(K) Number: K163106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: 9190002GF
• Device Catalogue Number: 9190002GF
• Device Lot Number: 6025714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown