MAUDE Adverse Event Report: NINGBO LUKE MEDICAL DEVICES CO., LTD JP CHAN DRN SIL HUBLESS 15FR W/TRO; ACCESSORIES, CATHETER

Model Number	JP-2229
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported we have had multiple complaints from surgeons that they are having trouble removing the drain post-op as well as problems after the drain is removed.One patient was brought back to the or after removing their drain.Patient had a breast procedure and had the drain placed for 8 days and when the physician was removing the drain 8 days later, they had difficulty doing so and it caused the tissue expander to flip.The patient was taken back to surgery under general anesthesia to have the expander replaced.Patient did fine and was released and no further details provided.
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
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.
Additional Manufacturer Narrative
End user customer did not provide the corresponding lot number or return any samples for investigation.Since no samples were returned for investigation, the root cause could not be determined.Device history record (dhr) review was unable to be completed as no lot number was provided.The site will continue to monitor complaints and trends related to the reported failure.

• Brand Name: JP CHAN DRN SIL HUBLESS 15FR 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 IL 31540 0; CH 315400
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15440064
• Report Number: 1423537-2022-00839
• Device Sequence Number: 12158170
• Product Code: KGZ
• UDI-Device Identifier: 10885380182617
• UDI-Public: 10885380182617
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup,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-2229
• Device Catalogue Number: JP-2229
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 08/19/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 12/02/2022; 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 Sex: Female