MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION CAUTERY HIGH TEMP FINE TIP; AA01

Catalog Number AA01

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Distributer received a box of 9 of 10 cauteries with open pouch.Cauteries model aa01 sterile lot 0816j lot # 2016-08-06.The returned product was inspected and it was confirmed that the pouched units were unsealed.No additional complaints have been received for this catalog number aa01 manufacturing lot number 2016-08-06, sterile lot 0816j.Review of the batch record showed no non-conformance noted during the pouching process, packaging or qc inspection processes.Employees were made aware of the event and the sealing and packaging employees were instructed to assure adequate handling and separation of unsealed pouches.

Event Description

Customer received a box with 9 of 10 unsealed pouches.

• Brand Name: CAUTERY HIGH TEMP FINE TIP
• Type of Device: AA01
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: julie mcdonald ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7278038554
• MDR Report Key: 6157513
• MDR Text Key: 61863870
• Report Number: 3007593903-2016-00012
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: AA01
• Device Lot Number: 0816J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• 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