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

Model Number 490100

Device Problem Grounding Malfunction (1271)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during inspection of the bd prepstain¿ the field service engineer physically felt residual electrical current when touching the device.No injury, adverse event, or impact to patient results was reported.The root cause was determined to be a failure within the customer¿s power outlet, and the service was halted until the facility could correct the electrical issue.

Manufacturer Narrative

Investigation summary: complaint reports electrical leak on prepstain (catalog number 490100) serial number (b)(6).Complaint alleges during inspection of the instrument electrical leakage of current was discovered.No injury, adverse event, or impact to patient results were reported.It was determined to be a failure within the customer facility's power outlet that caused the grounding issue.The facility corrected the power outlet grounding issue.Post intervention the instrument was left operating normally.Root cause is attributed to poor grounding at customer building.This complaint is not a confirmed failure of the instrument due to improper power outlet grounding at customer site.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) 2020.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 "safety." the bd prepstaintm instrument has been designed and manufactured in such a way as to reduce, as far as possible, the risks of fire or explosion during normal use and in single fault condition.It meets the requirements of the following standards: iec 61010-1:2010 (ed.3), ul 61010-1 (ed.3), safety requirements for electrical equipment for measurement, control, and laboratory use - part 1 ¿ general requirements.All ul testing has been performed on this instrument platform and was found to be compliant with the aforementioned international regulation(s).The requirements contained in the standard(s) have been satisfied: testing in single fault conditions which could cause the spread of fire outside the instrument, elimination or reduction of the sources of ignition within the instrument, and containment of a fire within the instrument, should it occur.

Event Description

It was reported that during inspection of the bd prepstain¿ the field service engineer physically felt residual electrical current when touching the device.No injury, adverse event, or impact to patient results was reported.The root cause was determined to be a failure within the customer¿s power outlet, and the service was halted until the facility could correct the electrical issue.

• 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
• 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: 13022084
• MDR Text Key: 288098315
• Report Number: 1119779-2021-01974
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904901004
• UDI-Public: 00382904901004
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1