MAUDE Adverse Event Report: NINGBO LUKE MEDICAL DEVICE CO LTD 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	Insufficient Information (4580)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, no lot number, sample photo, or returned sample was provided for investigation.The supplier cannot confirm the complaint product is produced by them.However, supplier reviewed the last 3 lot numbers shipped n210368, n210468 and n220050.There is no abnormality found during production and inspection.Supplier tested the retained samples from last 3 lot numbers shipped.The connection strength test results meet the product specifications.These products are disposable and cannot be reused.Icons are indicated in the labels.Based on testing and the information provided, the root cause cannot be determined.
Event or Problem Description
During removal of jp drain from the patient's scalp, the junction between the clear drain tubing and fluted white piece appeared to be severed and emerged from scalp, leaving the length of the subgaleal portion retained in the wound.This is the 3rd event that this has happened at our institution with the same drain.No further information was provided.

• Brand Name: JP CHAN DRN SIL FLT 7MM FULL W/TRO
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): NINGBO LUKE MEDICAL DEVICE CO LTD; no 178 gujiayan yangming st; yuyao city; zheziang 31540 0; CH 315400
• Manufacturer (Section G): NINGBO LUKE MEDICAL DEVICE CO LTD; no 178 gujiayan yangming st; yuyao city; zheziang 31540 0; CH 315400
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16907876
• Report Number: 1423537-2023-00935
• Device Sequence Number: 15163102
• Product Code: KGZ
• UDI-Device Identifier: 10885380182495
• UDI-Public: 10885380182495
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: JP-2212
• Device Catalogue Number: JP-2212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/10/2023
• 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
• Patient Sex: Unknown