MAUDE Adverse Event Report: COVIDIEN DOVER CATHETER PLUG WITH CAP; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER

Model Number REF 1600

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/29/2019

Event Type  Injury  

Event Description

Defect in covidien catheter plug led to leakage of urine from suprapubic tube.Cap was attached to suprapubic tube at time of hosp discharge from (b)(6) hosp, (b)(6) campus.One day later, pt noticed clothing was wet.Examination of cap revealed steady leakage from barrel of cap.Catheter plug lot #1820404664.Dates of use: (b)(6) 2019.Diagnosis or reason for use: cap for suprapubic tube.

• Brand Name: DOVER CATHETER PLUG WITH CAP
• Type of Device: URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 20248
• MDR Report Key: 9076008
• MDR Text Key: 159035451
• Report Number: MW5089826
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 09/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 1600
• Device Lot Number: 1820404664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95