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

Catalog Number 256082

Device Problem Leak/Splash (1354)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

A device 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 while testing for sars cov-2 sample leakage was observed in 19 cartridges.There was no report of impact.Eua#: (b)(4).The following information was provided by the initial reporter: "19 cartridges found minor leak after the 15mins incubation time, before inserted the cartridge into the analyzer.C line are seen on these 19 cartridges, result of these 19 cartridges is negative.After inserted these 19 cartridges into the analyzer, the leakage is more obvious after pulling out from the analyzer base on the moist level.".

Manufacturer Narrative

This complaint should be considered cancelled.This particular event would require the user to acquire replacement material in order to use as intended.This event results in user dissatisfaction.These physical defects do not negatively affect the results, and would render the product unusable.This is not a reportable event.

Event Description

It was reported while testing for sars cov-2 sample leakage was observed in 19 cartridges.There was no report of impact.Eua#: (b)(4).The following information was provided by the initial reporter: "19 cartridges found minor leak after the 15mins incubation time, before inserted the cartridge into the analyzer.C line are seen on these 19 cartridges, result of these 19 cartridges is negative.After inserted these 19 cartridges into the analyzer, the leakage is more obvious after pulling out from the analyzer base on the moist level.".

• 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): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11975945
• MDR Text Key: 267142469
• Report Number: 3006948883-2021-00677
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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: 06/18/2021
• Device Catalogue Number: 256082
• Device Lot Number: 1012038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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