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

Model Number JP-2214

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 326004883
• Report Number: 1423537-2023-00997
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 10885380182518
• UDI-Public: 10885380182518
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 80 KG