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

Model Number	9190002GFB
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported green stains in the disposable codman cord and tubing ((b)(4)).No additional information was provided after several attempts.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 disposable 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.
Event or Problem Description
N/a.

• Brand Name: C AND T SET FLYING LEADS GF BULK
• 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: 13481153
• Report Number: 3014334038-2022-00018
• Device Sequence Number: 5364192
• Product Code: GEI
• UDI-Device Identifier: 10381780521761
• UDI-Public: 10381780521761
• 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,Company Representative
• 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: 9190002GFB
• Device Catalogue Number: 9190002GFB
• Device Lot Number: J82F17
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• 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