MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD MULTI-CHECK; MIXTURE, HEMATOLOGY QUALITY CONTROL

Model Number	349704
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd multi-check control there was incorrect label information.The following information was provided by the the initial reporter: it was reported by the customer that when the r&d multi-check controls (349701 and 349704) come directly from r&d, the 2d barcode can be read by the facsduet.But when the r&d controls are repackaged for bdb the qr barcode on the tube is not compatible with the duet.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: based on the investigation results, the reported issue of failed bar code recognition was not confirmed.Investigation results that were performed on the indicated failure mode were the following: approved artwork for the multicheck control product was obtained and printed successfully at bdb.Documentation for recent lots of part lot 349704 was reviewed and found free of non-conformances an isolated report of failed bar code recognition suggests malfunction of the customer¿s instrumentation system.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during use with the bd multi-check control there was incorrect label information.The following information was provided by the initial reporter: it was reported by the customer that when the r&d multi-check controls (349701 and 349704) come directly from r&d, the 2d barcode can be read by the facsduet.But when the r&d controls are repackaged for bdb the qr barcode on the tube is not compatible with the duet.

• Brand Name: BD MULTI-CHECK
• Common Device Name: MIXTURE, HEMATOLOGY QUALITY CONTROL
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17359067
• Report Number: 2916837-2023-00143
• Device Sequence Number: 15188677
• Product Code: JPK
• UDI-Device Identifier: 00382903497041
• UDI-Public: 00382903497041
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: 349704
• Device Catalogue Number: 349704
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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