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

Model Number 443327

Device Problem Patient Data Problem (3197)

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

Event Date 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).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 instrument bd totalys multiprocessor a misassociation was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "in the datalink, customer found two different patients associated with one single c-tube barcode.".

Manufacturer Narrative

Investigation summary: a failure of c-tubes with duplicate barcodes was reported on a multiprocessor instrument (p/n 443327, s/n (b)(6).The customer reported that a single c-tube barcode corresponded in datalink to two different patients.A bd field service engineer was dispatched and reviewed the log files.The log files revealed that each of the runs were aborted so there was no warning of duplicate tubes.The fse advised some recommendations to the customer to avoid these issues in the future.This is an unconfirmed failure of a bd product.Bd quality did not receive any returned materials for review.Review of device history record for (b)(6) is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Service history for (b)(6) was reviewed and revealed no previous complaints related to duplicate barcodes.The root cause was attributed to user workflow and mishandling of c-tubes.Bd quality will continue to closely monitor for trends associated with this complaint.

Event Description

It was reported that while using instrument bd totalys multiprocessor a misassociation was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " in the datalink, customer found two different patients associated with one single c-tube barcode.".

• Brand Name: INSTRUMENT BD TOTALYS MULTIPROCESSOR
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12426019
• MDR Text Key: 275495537
• Report Number: 1119779-2021-01472
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904433277
• UDI-Public: 00382904433277
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: UNKNOWN
• 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: 03/02/2022

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: 443327
• Device Catalogue Number: 443327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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