MAUDE Adverse Event Report: BD DIAGNOSTICS - TRIPATH PREPSTAIN TECAN II

Catalog Number 490407

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/18/2014

Event Type  malfunction  

Event Description

Customer reported that the trap jar on their schuco pump exploded.The customer stated that the pressure reading on the gauge shot up suddenly and the trap jar exploded.No one was hurt or injured but plastic fragments were dispersed through the area and into the air.Customer was contacted for further information and the customer indicated that the incident occurred after they adjusted the pressure gauge to be within the correct range.

Manufacturer Narrative

The prepstain system is a liquid-based thin layer cell preparation process.The prepstain system converts a liquid suspension of a cervical cell sample into a discretely stained, homogeneous thin-layer of cells while maintaining diagnostic cell clusters.2-9.The process includes cell preservation, randomization, enrichment of diagnostic material, pipetting, sedimentation, staining, and coverslipping to create a surepath slide for use in routine cytology screening and categorization as defined by the bethesda system.Bd quality confirmed customer complaint based on the returned vacuum pump.Initial review suggest a likely implosion due to vacuum suction on a weakened trapjar.The unit will be returned to the manufacturer for confirmation.Bd has received no other complaints on this type of failure.A supplemental report will be filed with investigation results.

• Brand Name: PREPSTAIN TECAN II
• Manufacturer (Section D): BD DIAGNOSTICS - TRIPATH; mebane NC
• Manufacturer (Section G): BD DIAGNOSTICS - TRIPATH; 1022 corporate park drive; mebane NC 27302
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton circle; sparks, MD 21152-0000 ; 4103164367
• MDR Report Key: 4269458
• MDR Text Key: 5027738
• Report Number: 3008007472-2014-00001
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 490407
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1