MAUDE Adverse Event Report: NINGBO LUKE MEDICAL DEVICES CO., LTD JP CHAN DRN SIL RND 10FR FULL W/TRO; ACCESSORIES, CATHETER

Model Number JP-2187

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1980

Event Type  malfunction  

Manufacturer Narrative

Customer cannot confirm the actual complaint lot number.Supplier reviewed device history record (dhr) from the last five months.They found no abnormality during production and inspection.No sample available for investigation.The supplier tested their retained samples from 3 lot numbers produced in the last 5 months (n210460, n210468 and n210278).The tests include breaking strength test and drain measurements.The test results meet the product specifications.Based on the investigation result for the retained samples, the products meet the product specification.Therefore, without the complaint sample, lot number or additional information, the supplier is not able to determine a root cause for this complaint.

Event Description

Customer reported the wound drains were stiff and not flexible enough to make them easy to work with.The customer also reported that one drain broke off when it was being removed from the patient.The complaint samples, photos and lot numbers were not provided by the customer.

Manufacturer Narrative

Mdr supplemental report being filed due to the manufacturer name and address in sections d3, f14, and g1 entered incorrectly.The correct information is now being submitted.No other changes to the report are required.

• Brand Name: JP CHAN DRN SIL RND 10FR FULL W/TRO
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): NINGBO LUKE MEDICAL DEVICES CO., LTD; 178 gujiayan, qishan village; yangming street; yuyao city IL 31540 0; CH 315400
• Manufacturer (Section G): NINGBO LUKE MEDICAL DEVICES CO., LTD; 178 gujiayan, qishan village; yangming street; yuyao city 31540 0; CH 315400
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15279357
• MDR Text Key: 305179496
• Report Number: 1423537-2022-00822
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 20885380182423
• UDI-Public: 10885380182426
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022,12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JP-2187
• Device Catalogue Number: JP-2187
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1