MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ AT-HOME COVID-19 TEST; NOT CLASSIFIED

Catalog Number 256094

Device Problem Missing Information (4053)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

It was reported that one of the test sticks in the bd veritor¿ at-home covid-19 test was missing.There was no report of patient impact and no confirmatory testing took place.The following information was provided by the initial reporter: problem description: received a case of kits for r&d studies.One of the test-sticks was missing a bar code or other printing.Date of event or issue: (b)(6) 2021.Lot number (on outside of box by the qr code): 1277179.Was there any report of adverse medical impact? if so what? no.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Product is eua.(b)(4).

Manufacturer Narrative

H6: investigation summary this summarizes the investigation results regarding a complaint that alleges the bd veritor at home covid-19 test (material # 256094), batch number 1277179, ¿test stick was missing the barcode and other printing¿.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation was performed on the batch number provided.Results were acceptable and no relevant issue was found.All returned photographs were reviewed.The complaint was confirmed.The root cause was identified as a manufacturing-related issue.Currently, there are no adverse trends identified for labeling/packaging issues.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

Event Description

It was reported that one of the test sticks in the bd veritor¿ at-home covid-19 test was missing.There was no report of patient impact and no confirmatory testing took place.The following information was provided by the initial reporter: problem description: received a case of kits for r&d studies.One of the test-sticks was missing a bar code or other printing.Date of event or issue: 11/03/2021.Lot number (on outside of box by the qr code): 1277179.Was there any report of adverse medical impact? if so what? no.

• Brand Name: BD VERITOR¿ AT-HOME COVID-19 TEST
• Type of Device: NOT CLASSIFIED
• 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: 12798678
• MDR Text Key: 284888627
• Report Number: 1119779-2021-01803
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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 Expiration Date: 03/22/2022
• Device Catalogue Number: 256094
• Device Lot Number: 1277179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1