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

Catalog Number AA01

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Distributor received (1) one unit of the aa01 with lot # 2016-01-01, sterile lot # 0116a with unsealed pouch.The returned product was inspected and it was confirmed that the pouched unit was unsealed.It was confirmed that the pouches never went through the sealer as there was no evidence of marks in the seal.No additional complaints for unsealed pouches have been received for aa01 with lot # 2016-01-01 sterile lot # 0116a.This the first instance of this event for this product and product family.Review of the batch record showed no non-conformances noted during pouching, packaging or qc inspection processes.Our investigation suggests this to be an isolated event.The investigation concluded that the aa01 pouch was not sealed due to improper workflow and handling by the packaging operator.During the investigation, it was observed that improper handling provided the potential opportunity for an unsealed unit to be placed into the container with sealed pouches.Although qc random sampling inspection for sealed pouches is performed on every container, it did not detect this single unit.Employees were made aware of the event, and the pouch sealing employees were instructed to assure adequate handling and separation of unsealed pouches.In addition, the sealing process will be provided with a mechanism to collect sealed pouches without the assistance of the operator.Also, a new reconciliation process will be implemented to assure that unsealed and sealed pouches quantities are verified prior to subsequent boxing operations and product release.

Event Description

Distributor received (1) one unit with unsealed pouch.

• Brand Name: BOVIE MEDICAL
• Type of Device: CAUTERY HIGH TEMP FINE TIP
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: julie mcdonald ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7278038554
• MDR Report Key: 5797724
• MDR Text Key: 50620673
• Report Number: 3007593903-2016-00002
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: AA01
• Device Lot Number: 0116A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1