MAUDE Adverse Event Report: NINGBO LUKE MEDICAL DEVICES CO., LTD UNKNOWN PRODUCT-MED; ACCESSORIES, CATHETER

Model Number UNKNOWN PRODUCT-MED

Device Problems Disconnection (1171); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2022

Event Type  Injury  

Event Description

Jackson-pratt drain removed but perforated distal portion of the drain disconnected from the clear tubing and required removal by physician at bedside with hemostats.

Manufacturer Narrative

Device history record was reviewed for the reported lot number, n210469.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records for any of the fourteen product numbers associated with the reported lot.Customer did not provide the corresponding product number or return any samples for investigation.Since no samples were returned for investigation, the root cause could not be determined.Supplier tested the connection strength and breaking strength of retained samples from the reported lot.The test results confirmed this lot meets the products specifications.The site will continue to monitor complaint trends.

• Brand Name: UNKNOWN PRODUCT-MED
• 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): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15921372
• MDR Text Key: 304868758
• Report Number: 1423537-2022-00865
• Device Sequence Number: 1
• Product Code: KGZ
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: N210469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/10/2022
• Event Location: Hospital
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1