MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT RSV 30 TEST HOSPITAL VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Model Number 256042

Device Problem Inaccurate Information (4051)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k121633.

Event Description

It was reported that while using kit rsv 30 test hospital veritor incorrect label information was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: "it was reported that typos in sds occurred.Customer problem: customer reports typos in sds.Customer reports typo on sds with reagent c being listed as reagent d.Reagent c also has a warnings listed in package insert (h302, h402, h412).Customer requests corrected sds".

Manufacturer Narrative

H6: investigation summary this memo is to summarize the investigation results regarding the complaint that alleges typo on sds with reagent c being listed as reagent d when using kit rsv 30 test hospital veritor (material # 256042), batch number unknown.Bd quality performs a systematic approach to investigate labeling complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.An investigation was performed.The complaint was confirmed.The customer was supplied with an updated safety data sheet.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

Event Description

It was reported that while using kit rsv 30 test hospital veritor incorrect label information was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: "it was reported that typos in sds occurred.¿ customer problem: customer reports typos in sds.Customer reports typo on sds wit reagent c being listed as reagent d reagent c also has a warnings listed in package insert (h302,h402,h412).Customer requests corrected sds".

• Brand Name: KIT RSV 30 TEST HOSPITAL VERITOR
• Type of Device: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11671975
• MDR Text Key: 267334053
• Report Number: 3006948883-2021-00391
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133140
• 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: 02/14/2022

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 Model Number: 256042
• Device Catalogue Number: 256042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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