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

Model Number JP-2229

Device Problem Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/19/2022

Event Type  Injury  

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.

Event Description

Customer reported we have had complaints from surgeons that they are having trouble removing the drain post-op as well as problems after the drain is removed.One patient had bleeding following removal of the drain and had to be taken back to surgery to correct the issue.

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.

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
• 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 IL 31540 0; CH 315400
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15439959
• MDR Text Key: 300069537
• Report Number: 1423537-2022-00838
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 10885380182617
• UDI-Public: 10885380182617
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female