MAUDE Adverse Event Report: DEGANIA SILICONE, INC. JP CHAN DRN SIL FLT 7MM FULL W/TRO; ACCESSORIES, CATHETER

Model Number	JP-2212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Mw5148639: the neuro aprn(advanced registered nurse practitioner) attempted to remove the jp (jackson-pratt) drain which broke at the insertion site and a drain fragment remained in the patient.The neurosurgeon attempted to remove the fragment at the bedside without success.The pt returned to the or(operating room) for surgical removal of the jp drain fragment.
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.
Additional Manufacturer Narrative
A broken sample was returned for evaluation; tensile testing of the sample to assess its tightness could not be performed due to the broken sample.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 CHAN DRN SIL FLT 7MM FULL 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: 18505281
• Report Number: 1423537-2024-00004
• Device Sequence Number: 8125135
• Product Code: KGZ
• UDI-Device Identifier: 10885380182495
• UDI-Public: 10885380182495
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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-2212
• Device Catalogue Number: JP-2212
• Device Lot Number: P1942820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/20/2023
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2020
• 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 Age: 87 YR
• Patient Sex: Male
• Patient Weight: 66 KG