MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SUCTION CATHETER IN C-SECTION PACK

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

The account reported the tip of a suction catheter was discovered to be missing during a c-section.Account stated there did not appear to be any fracture lines on the catheter, but could not rule out the tip breaking and falling into the surgical site.The surgical site was surgically explored and the tip was not found.The patient was monitored and no adverse medical problems occurred.The account listed both cardinal health and medline as the manufacturers.Multiple attempts were made to obtain a product number was not provided for the c-section pack or for the suction catheter device.The suction catheter was returned and the root cause cannot be determined.However, it cannot be ruled out that the tip was broken prior to use or user error as a factor.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported that the tip of a suction catheter may have broken and fallen into a surgical site.

• Type of Device: SUCTION CATHETER IN C-SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093
• MDR Report Key: 6742361
• MDR Text Key: 81136785
• Report Number: 1423395-2017-00020
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention