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 Leak/Splash (1354)

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

Event Date 05/03/2022

Event Type  Injury  

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 assistant in nursing used the control swab from the bd rapid detection of sars-cov-2 veritor¿ to test herself, therefore, exposing herself to reagent.Eua# (b)(4).The following information was provided by the initial reporter: the receptionist from care home called to say that an ain (assistant in nursing) didn't follow the instructions of use & used the green swab ( sars cov-2 (+) control swab in green satchel) to perform a sars cov-2 test on herself at 8am this morning & tested positive.The ain repeated the test using a clean swab & tested positive again.There concern was whether the ain became infected by the positive control swab.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges exposure to reagent when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number 1270839.Bd quality performs a systematic approach to investigate exposure to reagent complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.A batch history record (bhr) review and retain sample analysis were not performed for this reported issue due to the nature of the complaint and it was not alleging any product quality.Based on the primary investigation understood that customer did not follow the instructions properly.Swab controls are supplied with each kit.These swab controls should be used to ensure that the test reagents work properly and that the test procedure is performed correctly.For kit swab controls, insert the control swab into the extraction reagent tube and vigorously plunge the swab up and down for 15 seconds and need to be tested to verify.If the kit controls do not perform as expected, do not report patient results.The complaint was unable to be confirmed.The root cause could not be identified.Currently no adverse trend for exposure to reagent was identified.Bd quality will continue to closely monitor for trends.If you have any add ions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported that the assistant in nursing used the control swab from the bd rapid detection of sars-cov-2 veritor¿ to test herself, therefore, exposing herself to reagent.Eua# (b)(4).The following information was provided by the initial reporter: the receptionist from care home called to say that an ain (assistant in nursing) didn't follow the instructions of use & used the green swab ( sars cov-2 (+) control swab in green satchel) to perform a sars cov-2 test on herself at 8am this morning & tested positive.The ain repeated the test using a clean swab & tested positive again.There concern was whether the ain became infected by the positive control swab.

• 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: 14578754
• MDR Text Key: 293279236
• Report Number: 3006948883-2022-00125
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/09/2022
• Device Catalogue Number: 256089
• Device Lot Number: 1270839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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
• Patient Outcome(s): Other