MAUDE Adverse Event Report: CLINICAL INNOVATIONS EBB; OBSTETRIC CATHETER

Model Number BD OTS

Device Problems Deflation Problem (1149); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/20/2017

Event Type  malfunction  

Event Description

Ebb balloon placed (b)(6) 2017 in the afternoon for uterine atony.Around 2200 dr noticed there was clearer fluids coming into the drain.In am (b)(6) 2017, balloon was deflated and only 30 cc was able to be removed from uterine balloon so dr removed the balloon and the uterine balloon was deflated (suppose to have 750 cc in it.) two rn's try to refill the uterine balloon and visualized an active leak in uterine balloon.

• Brand Name: EBB
• Type of Device: OBSTETRIC CATHETER
• Manufacturer (Section D): CLINICAL INNOVATIONS; salt lake UT 84123
• MDR Report Key: 6736179
• MDR Text Key: 80892517
• Report Number: MW5071161
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD OTS
• Device Catalogue Number: BD OTS
• Device Lot Number: 0116-R-222
• 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 Age: 35 YR
• Patient Weight: 113