MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number SMA12LPKGR

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

Physician inserted a 14fr silastic catheter at the beginning of her total laparoscopic hysterectomy and later during the case, the balloon of the catheter had popped.The balloon had no contact with an energy source or sharp instrument.The catheter is part of the cardinal gynecology laparoscopy pack, sma12lpkgr, lot 575492, exp date 2022-08-01.Catheter was saved.

• Brand Name: CARDINAL HEALTH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 10704709
• MDR Text Key: 212102068
• Report Number: 10704709
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMA12LPKGR
• Device Catalogue Number: SMA12LPKGR
• Device Lot Number: 575492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA