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

Model Number	491103
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no 510(k) for this device but is considered to be substantially similar to the legally u.S.Marketed device bd prepstain¿ catalog number :490100 with 510k#: p970018.Product number: 491103 is a class iii ivd in the us.Associate pma number is p970018.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 the bd prepstain¿ it failed to puncture four surepath vials.As a result, the customer got three slides with no cells an one slide with cells.The customer reports that four slides should be blank, but one of the four slides has cells.Customer also reports there are 40 cells on multiple 10x fovs and is concerned of possible cross contamination.No patient impact was reported.The following information was provided by the initial reporter: customer reports the prepmate failed to puncture 4 surepath vials.As a result, they got 3 slides with no cells and one slide with cells.Customer reports 4 slides should be blank, but one of the 4 slides has cells.Affected slide: customer reports 40 cells on multiple 10x fovs and concerned of possible cross contamination.Customer says this issue happened one time and most likely caused by operator's error.Customer confirms they report no issues with consumables or instrument.Customer had to get off the phone and declined further investigation or troubleshooting.
Event or Problem Description
It was reported that while using the bd prepstain¿ it failed to puncture four surepath vials.As a result, the customer got three slides with no cells an one slide with cells.The customer reports that four slides should be blank, but one of the four slides has cells.Customer also reports there are 40 cells on multiple 10x fovs and is concerned of possible cross contamination.No patient impact was reported.The following information was provided by the initial reporter: customer reports the prepmate failed to puncture 4 surepath vials.As a result, they got 3 slides with no cells and one slide with cells.- customer reports 4 slides should be blank, but one of the 4 slides has cells.- affected slide: customer reports 40 cells on multiple 10x fovs and concerned of possible cross contamination.- customer says this issue happened one time and most likely caused by operator's error.- customer confirms they report no issues with consumables or instrument.- customer had to get off the phone and declined further investigation or troubleshooting.
Additional Manufacturer Narrative
H.6 investigation summary: complaint reports sample transfer issues on prepmate (catalog number 491103) serial number (b)(6).Complaint alleges instrument failed to puncture four surepath vials.As a result three slides had no cells and one slide had cells causing concerns of possible cross contamination.Customer confirmed issue most likely caused by operator¿s error and reports no issues with the consumables or instrument.Root cause not determined, and this complaint is not a confirmed failure of the instrument based on the customer investigation.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on (b)(6) 2018.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "sample transfer.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15602299
• Report Number: 1119779-2022-01300
• Device Sequence Number: 13987518
• Product Code: MKQ
• UDI-Device Identifier: 00382904911034
• UDI-Public: 00382904911034
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 01/30/2023

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: 491103
• Device Catalogue Number: 491103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown