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

Model Number	JP-2214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 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
The drain tube broke when the surgeon was removing it from the patient.It left about a 5" piece inside the patient requiring patient to be returned to surgery for removal.The patient was returned to surgery for removal and administered medication for anesthesia and recovery.He was discharged in stable condition to skilled nursing.
Additional Manufacturer Narrative
No sample or photo were provided for evaluation therefore the supplier was unable to determine root cause for the reported issue.The batch record for lot number p22114035 was manufactured on 4/24/2023 with an expiration date of 4/24/2028.In-process controls contains tensile strength test of every batch of the drains.The batch passed tensile strength test (tear test) in the connection area.All the results were higher than minimum requirement.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: JP CHANNEL DRAIN 10MM, FULL FLUTES
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): DEGANIA SILICONE LTD.; degania bet; degania bet 15130 00 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD.; degania bet; degania bet, 15130 00 15130 00; IS 1513000
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17961686
• Report Number: 1423537-2023-00997
• Device Sequence Number: 5033603
• Product Code: KGZ
• UDI-Device Identifier: 10885380182518
• UDI-Public: 10885380182518
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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-2214
• Device Catalogue Number: JP-2214
• Device Lot Number: P22114035
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 80 KG