MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD SLIDEPREP PROCESSOR

Device Problems Signal Artifact/Noise (1036); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/19/2017

Event Type  malfunction  

Event Description

In (b)(6) 2016, i filed complaint number (b)(4) regarding the bd prepstain processor for surepath pap smears causing cross-contamination/transfer of one patients cells onto another patient's pap smear.Bd's response was to develop a new instrument called the slideprep.We have now identified 2 instances of cross-contamination and 14 of artifact on the slideprep instrument.Please contact me as soon as possible.Dr.(b)(6).

• Brand Name: BD SLIDEPREP PROCESSOR
• Type of Device: BD SLIDEPREP PROCESSOR
• Manufacturer (Section D): BECTON DICKINSON AND CO.
• MDR Report Key: 6893937
• MDR Text Key: 87496369
• Report Number: MW5072422
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other