MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; NOT CLASSIFIED

Catalog Number 256088

Device Problem Inaccurate Information (4051)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that 5 bd veritor ¿ sars-cov-2 & flu a+b kits had bd veritor ¿ sars-cov-2 cartridges inside the box.

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.G5: pma/510(k)#: item is also eua :(b)(4).

Manufacturer Narrative

H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges mix of product issue when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch numbers 3193518.The customer reported that they ordered 5 triplex kits and two of the triplex kits came with covid only testing cartridges, instead of the triplex testing cartridges.The extraction tubes were the correct covid/flu combo, only the cassettes were incorrect.Bd quality performs a systematic approach to investigate mix of product complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample analysis were performed on the batch number provided.Results were acceptable and no relevant issue was found.There are no risks of product mix identified via bhr review and retention sample check.No physical samples were received; therefore, return sample analysis could not be performed.However, the customer shared the photographs of affected kit confirming that they received covid only cartridges inside instead of the triplex test cartridge in the triplex kits.This complaint was confirmed based on the photographic evidence.Based on the information provided at this moment, no root cause was identified.Currently no adverse trend for mix of product was identified.Bd quality will continue to closely monitor for trends.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.The following fields have been updated with corrected and/or additional information.B5.Describe event: it was reported that two bd veritor ¿ sars-cov-2 & flu a+b kits had bd veritor ¿ sars-cov-2 cartridges inside the box.No patient impact reported.H3 other text : see h.10.

Event Description

It was reported that two bd veritor ¿ sars-cov-2 & flu a+b kits had bd veritor ¿ sars-cov-2 cartridges inside the box.No patient impact reported.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: NOT CLASSIFIED
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18219488
• MDR Text Key: 329913506
• Report Number: 3006948883-2023-00115
• Device Sequence Number: 1
• Product Code: QMN
• UDI-Device Identifier: 00382902580881
• UDI-Public: (01)00382902580881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256088
• Device Lot Number: 3193518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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