MAUDE Adverse Event Report: HALYARD HALYARD; C-SECTION FLUID COLLECTION DRAPE II WITH INCISE

Model Number 79529

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2019

Event Type  malfunction  

Event Description

Blood and fluid leaked through c-section drape onto patient.Event was discovered post procedure once the drape was removed from the patient.The drape was discarded so the lot number for the drape used in the procedure was not reported.Patient was given antibiotics post procedure.

• Brand Name: HALYARD
• Type of Device: C-SECTION FLUID COLLECTION DRAPE II WITH INCISE
• Manufacturer (Section D): HALYARD; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): RESOURCE OPTIMIZATION & INNOVATION, L.L.C.; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4177303937
• MDR Report Key: 8629014
• MDR Text Key: 145942909
• Report Number: 3014527682-2019-00001
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 79529
• Device Catalogue Number: 79529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1