MAUDE Adverse Event Report: CARDINAL HEALTH/MEDLINE INDUSTRIES STERILE C-SECTIN PACK CAUTERY

Lot Number 655334

Device Problem Fire (1245)

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

Event Date 04/14/2017

Event Type  malfunction  

Event Description

Pencil cautery that was part of a c-section pack prepared by (b)(6), the tip of the bovie caught on fire and was removed from use before injury to patient.Pencil cautery is made by (b)(4), however, since it comes as part of the c-section pack there is no lot number for the cautery itself.

• Brand Name: STERILE C-SECTIN PACK CAUTERY
• Type of Device: STERILE C-SECTIN PACK CAUTERY
• Manufacturer (Section D): CARDINAL HEALTH/MEDLINE INDUSTRIES; waukegan IL 60085
• MDR Report Key: 6500874
• MDR Text Key: 73063272
• Report Number: MW5069169
• Device Sequence Number: 1
• Product Code: OKV
• 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: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Lot Number: 655334
• 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
• Treatment: C-SECTION PACK PREPARED BY (B)(6). ; COVIDIEN PENCIL CAUTERY WAS CONTAINED IN THE
• Patient Outcome(s): Other
• Patient Age: 48 YR