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

Catalog Number 256094

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter state: state is unknown, md was used in its place.H.3.A devce 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 bd veritor ¿ at-home covid-19 test, the label is missing the expiration date.One kit was affected.There was no patient impact reported.The following information was provided by the initial reporter: "customer states he was going to perform a test and when he scan the product is stated to be expired, but he cannot locate any expiration date neither in the box, nor in the pouches that have the product.".

Manufacturer Narrative

H.6.Investigation summary: this summarizes the investigation results regarding a complaint that involving bd veritor at home covid-19 test (material # 256094), batch number 2314258.It was reported that when the customer was attempting to scan the test, it said the product had expired, but he could not locate any expiration date neither in the box, nor in the product pouches.Customer noted that he purchased this product in 2023 on amazon, he did not remember if it was in january or february.He was complaining about not having the expiry date stated on the package.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.A batch history record (bhr) review was performed on the batch number provided.The results were acceptable, and no relevant issues were found.Retained kits were visually inspected.During the inspection, all the kits were found to have expiry date information on the labels.Currently, there are no adverse trends identified for missing / incorrect labelling information.This complaint cannot be confirmed.The root cause could not be identified.

Event Description

It was reported that while using bd veritor ¿ at-home covid-19 test, the label is missing the expiration date.One kit was affected.There was no patient impact reported.The following information was provided by the initial reporter: "customer states he was going to perform a test and when he scan the product is stated to be expired, but he cannot locate any expiration date neither in the box, nor in the pouches that have the product.".

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17299463
• MDR Text Key: 319222610
• Report Number: 1119779-2023-00763
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 08/15/2023

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 Expiration Date: 05/18/2023
• Device Catalogue Number: 256094
• Device Lot Number: 2314258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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