MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JACKSON-PRATT HEMADUCT; CATHETER IRRIGATION

Model Number JP-HUR100

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/05/2018

Event Type  Injury  

Event Description

The drain was placed post-operative due to a large empty space after the goiter resection.The patient did well from surgery, and came back today to have her drain removed in clinic.The drain broke at the skin.We took her to the operating room tonight at uab np and remove the drain under local anesthesia with iv sedation without difficulty.We only had to remove 2 stitches and replace them.She did great and we will send her home today.

• Brand Name: JACKSON-PRATT HEMADUCT
• Type of Device: CATHETER IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 60085
• MDR Report Key: 7605304
• MDR Text Key: 111383811
• Report Number: MW5077883
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: JP-HUR100
• Device Catalogue Number: JP-HUR100
• Device Lot Number: 1131377
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 26