MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256089

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the box of a bd rapid detection of sars-cov-2 veritor¿ had the cartridge for a bd veritor flu a+b testing system.Eua # (b)(4).The following information was provided by the initial reporter: lab-tech from owc lab informed that they found a unusual bd veritor flu a+b device cartridge (just one piece) instead of the usual bd veritor¿ system sars-cov-2 device cartridge when taking out from the bd kit box.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges finding one bd veritor flu a+b device cartridge when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 1188402.Bd quality performs a systematic approach to investigate a product mix up.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation including reviewing all returned photographs were performed and concluded that the flu test was introduced during the pouching process of the sars kit.A capa 4148219 was opened to address this issue.The complaint was confirmed.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that the box of a bd rapid detection of sars-cov-2 veritor¿ had the cartridge for a bd veritor flu a+b testing system.Eua # (b)(4).The following information was provided by the initial reporter: lab-tech from (b)(6) lab informed that they found a unusual bd veritor flu a+b device cartridge (just one piece) instead of the usual bd veritor¿ system sars-cov-2 device cartridge when taking out from the bd kit box.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13061948
• MDR Text Key: 282634677
• Report Number: 3006948883-2021-01032
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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: 06/01/2022
• Device Catalogue Number: 256089
• Device Lot Number: 1188402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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