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

Model Number	JP-2215
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
(b)(4): patient had jp drain in her abdomen that was ordered to be removed.During removal of jp drain, the tip broke off and migrated through body and had to be removed through ir procedure.No additional information provided.
Additional Manufacturer Narrative
Mdr supplemental report being filed due to the manufacturer name and address in section g1 entered incorrectly.The correct information is now being submitted.No other changes to the report are required.

• Brand Name: JP CHAN DRN SIL FLT 10MM 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 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: 15629615
• Report Number: 1423537-2022-00853
• Device Sequence Number: 12252526
• Product Code: KGZ
• UDI-Device Identifier: 10885380182525
• UDI-Public: 10885380182525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: JP-2215
• Device Catalogue Number: JP-2215
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2022
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female