MAUDE Adverse Event Report: DEGANIA SILICONE, INC. JP CHANNEL DRAIN 10MM, FULL FLUTES; ACCESSORIES, CATHETER

Model Number	JP-2214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/01/2024
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 they had two incidents now that when removing the drain a piece breaks off and stays in the patient and they have to return to surgery for removal.No further information was provided.
Additional Manufacturer Narrative
A sample was not returned for evaluation.Without the broken sample, tensile testing of the sample to assess its tightness could not be performed.The supplier¿s in-process control contains tensile strength test of every batch of drains.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 10MM, FULL FLUTES
• 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: 18803254
• Report Number: 1423537-2024-00010
• Device Sequence Number: 7330997
• Product Code: KGZ
• UDI-Device Identifier: 10885380182518
• UDI-Public: 10885380182518
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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-2214
• Device Catalogue Number: JP-2214
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/01/2024
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/29/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown