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

Device Problem Difficult to Remove (1528)

Patient Problem Failure of Implant (1924)

Event Date 05/16/2022

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 301977859
• Report Number: 1423537-2022-00853
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 10885380182525
• UDI-Public: 10885380182525
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female