MAUDE Adverse Event Report: INTEGRA LIFESCIENCIES CORPORATION CAROTID STERIL LOOP SHUNT 3MM; STERILE SUNDT CAROTID LOOP SHUNT 3MM X 4MM

Model Number NL8505070

Device Problem Inaccurate Information (4051)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

There is no evidence of product malfunction or mislabeling from the manufacturer side.The device was re-labeled incorrectly at edwards warehouse for inventory purposes.Therefore, edwards lifesciences is reporting instead of the original manufacturer.Note that the code included in d2b is not applicable for this device since the carotid shunt is a preamendment device.One image was reviewed.The image showed two labels with different model number (ref.Nl8505066 and ref.Nl8505070).Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

As reported, this carotid shunt package was double labeled.Labels with different model number were stuck in the package, two labels with model number nl8505066 and one label with nl8505070.The customer had ordered a nl8505070, and they received a nl8505066.There was no patient involved.The device was not available for evaluation; however, there was an image available for evaluation.

• Brand Name: CAROTID STERIL LOOP SHUNT 3MM
• Type of Device: STERILE SUNDT CAROTID LOOP SHUNT 3MM X 4MM
• Manufacturer (Section D): INTEGRA LIFESCIENCIES CORPORATION; campus road, 1100; princeton NJ 08540
• Manufacturer (Section G): INTEGRA LIFESCIENCIES CORPORATION; campus road, 1100; princeton NJ 08540
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19182146
• MDR Text Key: 341788718
• Report Number: 2015691-2024-03146
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL8505070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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