MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PREPSTAIN; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number 490100

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd prepstain¿ cross-contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

H.6.Investigation: complaint reports dripping on edge of slides on prepstain (catalog number 490100) serial number (b)(6).Specifically, the customer reported sample dripping outside the cell circle on an occasional slide.No erroneous results were reported.Service dispatched and replaced diti tip, blue rubber gasket, and diti tubing.Post intervention, the instrument was left operating normally.Root cause is not determined and this complaint is not confirmed as no material was returned for investigation.Review of device history record for usps200406 is not needed due to the age of the instrument.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "diti errors." h3 other text : see h.10.

Event Description

It was reported that while using bd prepstain¿ cross-contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD PREPSTAIN
• Type of Device: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11558544
• MDR Text Key: 243816048
• Report Number: 1119779-2021-00550
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (y/n): N
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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: Other
• Device Model Number: 490100
• Device Catalogue Number: 490100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1