MAUDE Adverse Event Report: DEGANIA SILICONE, INC. JP CHAN DRN SIL HUBLESS 15FR W/TRO; ACCESSORIES, CATHETER

Model Number	JP-2229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that per the neurosurgeon, the order was given to remove jp drain on lower back prior to discharge.As the jp drain tube was being pulled out, there was some resistance.When the rn pulled the tubing, the end of the tubing was fragmented.Imaging was performed to conclude that the remaining piece was still in patient.No further information was provided.
Additional Manufacturer Narrative
Based on the supplier investigation, since no samples were returned for evaluation, a root cause could not be determined for the reported complaint.The supplier¿s in-process control contains tensile strength test of every batch of drains.Testing from retained samples from the same batch passed tensile strength test and the result was within test specification.Based on testing and the information provided, the root cause cannot be determined.

• Brand Name: JP CHAN DRN SIL HUBLESS 15FR W/TRO
• 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: 17092742
• Report Number: 1423537-2023-00948
• Device Sequence Number: 12430604
• Product Code: KGZ
• UDI-Device Identifier: 10885380182617
• UDI-Public: 10885380182617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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-2229
• Device Catalogue Number: JP-2229
• Device Lot Number: P1922015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/24/2023
• Date Device Manufactured: 06/13/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown