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

Model Number JP-2229

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 316844223
• Report Number: 1423537-2023-00948
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 10885380182617
• UDI-Public: 10885380182617
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/10/2023
• Date Device Manufactured: 06/13/2019
• 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
• Patient Outcome(s): Other