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

Model Number	JP-2233
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported physicians are having issues with the drain that is attached to a trocar, passing through the skin.The drain is stiff and hard to strip.Drainage is then low; the drain is removed, and seromas develop.An attempt to drain the seroma is not always successful.The plastics group recently had an infection.Seromas affect the adherence of dermal tissue and the physical appearance of the reconstructive surgery.No additional information or patient demographics provided.
Additional Manufacturer Narrative
Based on the supplier investigation, device history record (dhr) could not be reviewed as lot number was not provided.However, supplier had reviewed dhrs for the last five months.They found no abnormality during production and inspection for this product.No sample was available at the time of investigation.Supplier tested their retained samples from two lot numbers produced over the last five months (n210460 and n210468).Their tests included sharpness test, patency test, and drain measurements.The test results meet the products specifications.According to the complaint information that the patient had a seroma during the operation.Supplier had consulted with their medical consultant on this issue.However, there are many causes for a seroma.Based the information provided by customer, it is hard to determine the root cause for this seroma.Based on investigation, the supplier concluded that their products meet the product specification, and they cannot find the root cause of this complaint.There is no action taken at this time.Cardinal health will continue to monitor complaint trends.
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 HUBLES 15FR BND 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: 15280447
• Report Number: 1423537-2022-00824
• Device Sequence Number: 14051572
• Product Code: KGZ
• UDI-Device Identifier: 20885380182652
• UDI-Public: 10885380182655
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• 2 Devices were Involved in the Event: 1 2

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-2233
• Device Catalogue Number: JP-2233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 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): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown