MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR SUNDT INTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M; N/A

Catalog Number	NL8505060
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the physician attempted to use a carotid sundt internal w/non-reinforced segment 3mm x 4m (nl8505060), but observed that it was defective as the tubing looked "melted" in one area.Additional information has been requested.
Additional Manufacturer Narrative
The sundt internal w/non-reinforced segment 3mm x 4m (nl8505060) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, the device history record (dhr) did not identify any anomaly during the manufacturing and packaging process that could be related to the reported condition the root cause of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: SUNDT INTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17924128
• Report Number: 2648988-2023-00033
• Device Sequence Number: 16867318
• Product Code: DWF
• UDI-Device Identifier: 10381780211099
• UDI-Public: 10381780211099
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 11/22/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: NL8505060
• Device Lot Number: 699122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/22/2023
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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