MAUDE Adverse Event Report: CARDINAL HEALTH/MEDLINE STERILE C SECTION PACK; CESAREAN SECTION TRAY

Lot Number 655334

Device Problem Fire (1245)

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

Event Date 04/18/2017

Event Type  malfunction  

Event Description

During a c-section the tip of the pencil cautery, bovie, was placed on hemostat for coagulation and did not work properly.It was noted that the tip had ignited with a flame.This is the second pencil cautery that is packaged in a c-section pack by (b)(4) that has ignited unexpectedly and without patient harm.The pencil cautery is manufactured by (b)(4).

• Brand Name: STERILE C SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): CARDINAL HEALTH/MEDLINE; waukegan IL
• MDR Report Key: 6512477
• MDR Text Key: 73408742
• Report Number: MW5069245
• Device Sequence Number: 1
• Product Code: OHM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/20/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Lot Number: 655334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2017
• 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 Outcome(s): Other
• Patient Age: 33 YR