MAUDE Adverse Event Report: COOK, INC. COOK CERVICAL RIPENING BALLOON; CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR

Model Number J-CRBS-184000

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

Patient admitted for induction of labor in the evening and had a cervical ripening balloon inserted through her cervix.Both the intrauterine and vaginal balloon were inflated with 80ml of sterile saline and gentle tension was applied to the catheter.The next morning, the patient reported that she was leaking fluid all night.The nurse applied gentle tension on the catheter and it came out of the vagina in its entirety.The vaginal balloon was visibly leaking and almost completely deflated and the uterine balloon was not fully inflated.Fda safety report id# (b)(4).

• Brand Name: COOK CERVICAL RIPENING BALLOON
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
• Manufacturer (Section D): COOK, INC. ; bloomington IN 47402 4195
• MDR Report Key: 12040363
• MDR Text Key: 257735282
• Report Number: MW5101998
• Device Sequence Number: 1
• Product Code: PFJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J-CRBS-184000
• Device Lot Number: 13940035
• Was Device Available for Evaluation?: No
• 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: 37 YR
• Patient Weight: 107