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 Leak/Splash (1354)

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

Event Date 09/05/2023

Event Type  Injury  

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.

Event Description

It was reported that while using bd veritor ¿ sars-cov-2 & flu a+b that there was a splash of reagent.The following information was provided by the initial reporter: customer is reporting exposure from extraction tube to face and nose.Customer splashed herself on the face and nose with liquid from the extraction tube when taking out the positive control swab out of the extraction tube.

Event Description

It was reported that while using bd veritor ¿ sars-cov-2 & flu a+b that there was a splash of reagent.The following information was provided by the initial reporter: customer is reporting exposure from extraction tube to face and nose.Customer splashed herself on the face and nose with liquid from the extraction tube when taking out the positive control swab out of the extraction tube.

Manufacturer Narrative

H.6.Investigation summary: this summarizes the investigation results regarding a complaint that involved rapid detection of sars-cov-2 & flu a+b kit (material # 256088), batch number 3004372.The customer reported an exposure with liquid from extraction tube to face and nose.She splashed herself on the face and nose with liquid from the extraction tube when taking out the positive control swab out of the extraction tube.They didn't get any liquid in to her nose or eyes, only on skin but she did not rinse her skin after exposure.She only put a mask on.Bd representative advised the customer to follow their body fluid exposure protocol.Batch history record (bhr) review and retain sample testing were not required because of the nature of the complaint and no product issue were alleged.These reagents contain sodium azide, which is harmful if inhaled, swallowed, or exposed to skin.If there is contact with skin, wash immediately with plenty of water.Do not flush reagents down the drain.There is no product quality issue were alleged with this complaint.The complaint was unable to be confirmed.A trend analysis for this issue was conducted, and no adverse trend was identified.H3 other text : see h.10.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17760920
• MDR Text Key: 323582663
• Report Number: 3006948883-2023-00097
• Device Sequence Number: 1
• Product Code: QMN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203152
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/14/2024
• Device Catalogue Number: 256088
• Device Lot Number: 3004372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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
• Patient Outcome(s): Other