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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 314999573
• Report Number: 1423537-2023-00935
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 10885380182495
• UDI-Public: 10885380182495
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1