MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Model Number 256045

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/15/2022

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 that bd veritor¿ system for rapid detection of flu a+b clia-waved kit contained expired components.The quantity affected was four.No patient impact.The following information was provided by the initial reporter: customer reported that their veritor kit contained expired components.Product 256045 (lot#0133527 - expiry on 2023-04-26).For the product 256045, expiry date for the reagent tube was 2021-08-23 and test cartridge was 2021-09-24.

Manufacturer Narrative

H.6 investigation summary this summarizes the investigation results regarding a complaint that alleges veritor kit contained expired components."the expiry date for the reagent tube was 2021-08-23 and test cartridge was 2021-09-24" when using bd kit flu a+b 30 test physician veritor (material # 256045), batch number 0133527.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.A batch review was performed for the number provided.The results were acceptable.The retained sample analysis and return sample analysis were performed and found out that the reported issue bearing components (reagent tube and test cartridge) are not associated with batch number 0133527.It has been confirmed through sap and batch record data.Therefore, this complaint cannot be confirmed.Currently, there are no adverse trends identified for expired component.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit contained expired components.The quantity affected was four.No patient impact.The following information was provided by the initial reporter: customer reported that their veritor kit contained expired components.Product 256045 (lot#0133527 - expiry on 2023-04-26) for the product 256045, expiry date for the reagent tube was 2021-08-23 and test cartridge was 2021-09-24.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
• 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: 15392083
• MDR Text Key: 300872384
• Report Number: 3006948883-2022-00171
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160161
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/26/2023
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 0133527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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