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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1423537-2022-00822
• Device Sequence Number: 6193108
• Product Code: KGZ
• UDI-Device Identifier: 20885380182423
• UDI-Public: 10885380182426
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022
• Report Date (Section F): 07/27/2022

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-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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown