MAUDE Adverse Event Report: DEGANIA SILICONE, INC JACKSON-PRATT; CATHETER, IRRIGATION

Model Number	JP-2190
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
We had an unfortunate situation with the cardinal health jackson-pratt channel drains jp-2190 that we recently ordered.The channel part that goes under the skin, separated from the part that is outside of the skin, therefore causing the channel part to get stuck under the skin and the doctor had to open the area and retrieve the channel part of the drain.
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
The device history record was reviewed and the lot was inspected and released in compliance with all requirements.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported issue.No quality issues were detected during production and inspection.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: JACKSON-PRATT
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): DEGANIA SILICONE, INC; degania bet; 1513000; IS
• Manufacturer (Section G): DEGANIA SILICONE, INC; degania bet; 1513000; IS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23710419
• Report Number: 1423537-2025-00489
• Device Sequence Number: 16101029
• Product Code: GBX
• UDI-Device Identifier: 10885380182457
• UDI-Public: (01)10885380182457(10)P2434686
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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-2190
• Device Catalogue Number: JP-2190
• Device Lot Number: P2434686
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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