MAUDE Adverse Event Report: PURITAN MEDICAL PRODUCTS COMPANY LLC PURITAN HISTOBRUSH; CYTOLOGY BRUSH

Model Number 2199

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

The incident original reporter could not verify the lot number provided.This report and our investigation was conducted based on the indefinite report lot number.Batch records did not reveal any anomalies.Similar product was tested and the defect could not be reproduced.We will continue to monitor reports of similar events.

Event Description

Physician inserted the brush into the patient's cervix and after rotating it, the brush tip came out of the handle and remain in the patient's cervix.The physician was able to retrieve the brush readily.There is not any adverse events or injuries.

• Brand Name: PURITAN HISTOBRUSH
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): PURITAN MEDICAL PRODUCTS COMPANY LLC; 31 school street; po box 149; guilford ME 04443 0149
• Manufacturer Contact: william young ; 31 school street; po box 149; guilford, ME 04443-0149 ; 2078763311
• MDR Report Key: 5762513
• MDR Text Key: 48582323
• Report Number: 1216735-2016-00003
• Device Sequence Number: 1
• Product Code: HHT
• UDI-Device Identifier: 00609576250072
• UDI-Public: 0609576250072
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: 2199
• Device Catalogue Number: 2199
• Device Lot Number: 83150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention