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 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Eua (b)(4).Initial reporter first and last name: (b)(6).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 an incorrect component was found in a bd rapid detection of sars-cov-2 veritor¿ kit during use.The user did not proceed in testing with the incorrect cartridge.There was no report of patient impact.Eua (b)(4).The following information was provided by the initial reporter: the lab staff discovered an scov-2 flu a+b cartridge in a box of sars-cov-2 cartridges the lab staff then proceeded to re-drip on a new sars-cov-2 cartridge from the same box (lot no: 1307628) as instructed.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges ¿mixed product¿ when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 1307628.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 and testing were performed on the batch number provided.A photograph was returned and showed rapid detection of sars-cov-2 & flu a+b veritor test device.The allegation is this test device is believed to have come from the sars-cov-2 veritor ce (material # 256089) kit.Retention was performed and resulted with no "mixed product" found.Capa 4148219 was opened and during the investigation, it was discovered that during the kitting process, a small quantity of sars-cov-2 & flu a+b veritor test devices could have been introduced into the kits.The sars & flu test cassettes would still give the correct results.The root cause was identified as a manufacturing issue and steps have been taken to ensure this issue does not recur.

Event Description

It was reported that an incorrect component was found in a bd rapid detection of sars-cov-2 veritor¿ kit during use.The user did not proceed in testing with the incorrect cartridge.There was no report of patient impact.Eua(b)(4).The following information was provided by the initial reporter: the lab staff discovered an scov-2 flu a+b cartridge in a box of sars-cov-2 cartridges the lab staff then proceeded to re-drip on a new sars-cov-2 cartridge from the same box (lot no: 1307628) as instructed.

• 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: 13779144
• MDR Text Key: 287260245
• Report Number: 3006948883-2022-00080
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/20/2022
• Device Catalogue Number: 256089
• Device Lot Number: 1307628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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