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 01/13/2022

Event Type  malfunction  

Event Description

It was reported that the customer received one bd veritor ¿ at-home covid-19 test kit that was missing lot number and expiration date labeling.The kit was not used.Eua (b)(4).The following information was provided by the initial reporter: ordered multiple kits - one test kit came unlabeled.Not lot, no exp, just our reference number on the bottom.

Manufacturer Narrative

Eua (b)(4).Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation: this summarizes the investigation results regarding a complaint that alleges the ¿customers¿ bd veritor at home covid-19 test (material # 256094), batch number unknown, ¿was unlabeled, no lot or exp.¿ bd quality performs a systematic approach to investigate labeling/packaging issue complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation could not be performed because a batch number was not provided.The complaint was unable to be confirmed.The root cause could not be identified.Currently, there are no adverse trends identified for labeling/packaging issue.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that the customer received one bd veritor ¿ at-home covid-19 test kit that was missing lot number and expiration date labeling.The kit was not used.Eua(b)(4).The following information was provided by the initial reporter: ordered multiple kits - one test kit came unlabeled.Not lot, no exp, just our reference number on the bottom.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13501867
• MDR Text Key: 292039265
• Report Number: 1119779-2022-00218
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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: Lay User/Patient
• Device Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female