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 Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 08/04/2021

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 a broken bottle was observed.There was no report of impact.Eua#: (b)(6).The following information was provided by the initial reporter: " customer problem: ver 256082_1166537 vials split alongside when squeezed; connected to case # (b)(4) for issue with testing devices in the same kit.".

Event Description

It was reported while testing for sars cov-2 a broken bottle was observed.There was no report of impact.Eua#: eua (b)(4).The following information was provided by the initial reporter: "customer problem: ver 256082_1166537 vials split alongside when squeezed; connected to case # (b)(4) for issue with testing devices in the same kit".

Manufacturer Narrative

H6: investigation summary: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3006948883-2021-00894 was sent in error.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.In the event the test device leaks during use there is no increased risk to the user compared to normal use.This would require the user to acquire another component and could result in a clinical inconsequential prolongation in diagnostic identification.The leaking test device is unlikely to affect the reading of the next device.This is unlikely to cause serious injury or death.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12363497
• MDR Text Key: 268064994
• Report Number: 3006948883-2021-00894
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: 256082
• Device Lot Number: 1166537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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