MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD C AND T SET FIXED LEADS RP; DISPOSABLE CODMAN CORD AND TUBING

Catalog Number	9190001RP
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
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 "foreign matter" was observed inside the packaging of a disposable codman cord and tubing (id 9190001rp).The procedure was completed with a replacement product available.No patient injury/consequences.According to customer, there is no further information on the foreign matter.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The disposable codman cord and tubing (id (b)(4) was returned for evaluation.Failure analysis - the unit was evaluated via a visual inspection.The complaint could not be verified through failure analysis.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (dhr) review and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the dhr.Product was received for analysis and the investigation could not confirm the complaint.

• Brand Name: C AND T SET FIXED LEADS RP
• Common Device Name: DISPOSABLE CODMAN CORD AND TUBING
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21253405
• Report Number: 3014334038-2025-00012
• Device Sequence Number: 8038671
• Product Code: GEI
• UDI-Device Identifier: 10381780521747
• UDI-Public: 10381780521747
• 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: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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 Catalogue Number: 9190001RP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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