MAUDE Adverse Event Report: DEGANIA SILICONE, INC. JP CHANNEL DRAIN 10FR HUBLESS; ACCESSORIES, CATHETER

Model Number	JP-2226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated that the surgeon reported that the jp drain broke off inside of the patient.No injury was reported.The surgeon is not necessarily advocating something is wrong with the product, but he does want to be certain that his team is using it in the manner it is designed to be used.No further information was provided.
Additional Manufacturer Narrative
Device history record review for batch number p22113862 showed (b)(4) pieces produced (b)(6) 2023 , with expiration date of 01/24/2028.Supplier¿s in-process control contains tensile strength test of every batch of the drains.The batch passed the tensile strength test (tear test) in the tube part and the fluted part according to the test specification.Testing from retained sample from the same batch passed tensile strength test and the result was compliant within test specification.Based on testing and the information provided, the root cause cannot be determined.

• Brand Name: JP CHANNEL DRAIN 10FR HUBLESS
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): DEGANIA SILICONE, INC.; degania bet; 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE, INC.; degania bet; 15130 00; IS 1513000
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19015720
• Report Number: 1423537-2024-00013
• Device Sequence Number: 7939164
• Product Code: KGZ
• UDI-Device Identifier: 10885380182587
• UDI-Public: 10885380182587
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: JP-2226
• Device Catalogue Number: JP-2226
• Device Lot Number: P22113862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/05/2024
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/01/2024
• Date Device Manufactured: 01/24/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown