MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR(TM) SYS FOR RAPID DETECTION OF GROUP A STREP; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 256057

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/30/2021

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.

Event Description

It was reported that while using bd veritor(tm) sys for rapid detection of group a strep missing label information was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following fields were corrected with additional information: " the customer found an individual package of the strep a test plate in which no letter was printed in the white area.".

Manufacturer Narrative

H6: investigation: this statement is to summarize the investigation results regarding the complaint that alleges packaging issue (individual package of the strep a test plate in which no letter was printed in the white area) when using kit veritor system strep a 10 tests jp (material # 256057), batch number unknown.Bd quality performs a systematic approach to investigate packaging issue (individual package of the strep a test plate in which no letter was printed in the white area) 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 could not be performed as no batch number was provided.The complaint was unable to be confirmed.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that while using bd veritor(tm) sys for rapid detection of group a strep missing label information was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following fields were corrected with additional information: "the customer found an individual package of the strep a test plate in which no letter was printed in the white area.".

• Brand Name: BD VERITOR(TM) SYS FOR RAPID DETECTION OF GROUP A STREP
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: 13084541
• MDR Text Key: 283095077
• Report Number: 3006948883-2021-01034
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256057
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• 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