MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TAXO¿ TB NIACIN TEST STRIPS; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number 231741

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that prior to using bd bbl¿ taxo¿ tb niacin test strips, the incorrect ifu document is loading on the eifu website.No patient impact was reported.The following information was provided by the initial reporter: "customer reports that the incorrect document is loading on the eifu website - instead the taxo p disc document is loading.Technical services identified a discrepancy in the ifu record.No impact to patients or customers was associated with this discrepancy at this time.".

Event Description

It was reported that prior to using bd bbl¿ taxo¿ tb niacin test strips, the incorrect ifu document is loading on the eifu website.No patient impact was reported.The following information was provided by the initial reporter: "customer reports that the incorrect document is loading on the eifu website - instead the taxo p disc document is loading.Technical services identified a discrepancy in the ifu record.No impact to patients or customers was associated with this discrepancy at this time.".

Manufacturer Narrative

H.6 investigation summary: a complaint investigation due to incorrect eifu for strip tb niacin catalog 231741 was performed on retention samples.The investigation required to evaluate eifu website.Eifu website was evaluated and it was observed that the eifu is correct in the system.No discrepancies observed.Evidence provided by customer was evaluated.It was observed that the system included catalog 231741 as part of products included on eifu no.8800681jaa.Customer is aware that ifu 8800681jaa can't be used since it did not make reference to catalog 231741.As a corrective action eifu website was corrected.The bd labeling team has reviewed the issue and confirmed an incorrect document was displayed on the eifu site.A technical issue with the document link was identified as part of this complaint and a corrective and preventative action was initiated in order to ensure the issue is being addressed and corrected moving forward.Bd apologizes for any inconvenience this has caused.The bd eifu site also directs users to customer service in the event an error is in place with the site.A copy of the ifu can be requested by contacting bd technical services.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD BBL¿ TAXO¿ TB NIACIN TEST STRIPS
• Type of Device: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17313008
• MDR Text Key: 319216413
• Report Number: 1119779-2023-00770
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 00382902317418
• UDI-Public: 00382902317418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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
• Device Operator: Other
• Device Model Number: 231741
• Device Catalogue Number: 231741
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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