MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HELIPLUG; N/A

Catalog Number	62202
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported an heliplug (id 62202) almost melt.It disappeared into the socket and they need to use an extra plug.The device was used for tooth extraction.No patient injury was reported.
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
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10 the heliplug (id (b)(6)) was not returned for evaluation; however a retain sample of the same lot number was evaluated: device history records (dhr) - no anomalies failure analysis - retain sample evaluation was performed for fg lot 7122046.Eighty (80) units (2 shipper boxes with 4 dispenser boxes of 10 units each) were visually inspected.No anomaly was observed in the outer pack, tray sealing, or sponge appearance.Five (5) units were sampled and sent to the laboratory for testing.The method allows to determine the time the sample takes to completely wet out (visual saturation) once placed on the surface of purified water.The documented time (in seconds) met the product test requirements (< 20 seconds).All five (5) sponges were found to comply.Root cause - fg lot 7122046 met all in-process and fg requirements as specified in the packaging shop order and related procedures.

• Brand Name: HELIPLUG
• 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: 17868220
• Report Number: 2648988-2023-00032
• Device Sequence Number: 7490299
• Product Code: LPG
• UDI-Device Identifier: 10381780000303
• UDI-Public: 10381780000303
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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): 10/26/2023

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 62202
• Device Lot Number: 7122046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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