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

Model Number	490100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H.6.Investigation: complaint reports aspirator tip clogged on prepstain (catalog number 490100) serial number (b)(6).Specifically, the customer reported vacuum aspirator tip is getting clogged which caused a carry-over of cellular material to another slide.No erroneous results were reported.Customer was notified to replace the cleaning solution with contrad and to no longer use bleach.Customer also have been using only a drop or two of specimen when the samples are too thick viscous as recommended.Post intervention, the instrument was left operating normally.Root cause is not determined and this complaint is not a confirmed failure of the instrument.Review of device history record for (b)(6) 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 "quad errors." h3 other text : see h.10.
Event or Problem 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
• Common Device Name: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11572693
• Report Number: 1119779-2021-00561
• Device Sequence Number: 14519700
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P970018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 490100
• Device Catalogue Number: 490100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1