MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT; ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Catalog Number	256042
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to using bd veritor¿ system for rapid detection of rsv - laboratory kit, there were missing labels.No patient impact reported.The following information was provided by the initial reporter: "customer reports that labels are missing and they are unable to determine lot #s customer clarified that the issue is that the plastic bag in the photo is kit contents that came without a box, so they are unable to determine the lot # of the kit.".
Event or Problem Description
It was reported that prior to using bd veritor¿ system for rapid detection of rsv - laboratory kit, there were missing labels.No patient impact reported.The following information was provided by the initial reporter: "customer reports that labels are missing and they are unable to determine lot #s customer clarified that the issue is that the plastic bag in the photo is kit contents that came without a box, so they are unable to determine the lot # of the kit.".
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that involved kit rsv 30 test hospital veritor (material # 256042, batch number unknown.The customer reported missing labels with rsv kit, and they could not provide the lot number.While inquiring, they clarified that the kit contents came without a box, so they were unable to determine the lot # of the kit.Bd quality performs a systematic approach to investigate labeling / packaging issue 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 testing could not be performed because a batch number was not provided.No physical samples were returned; therefore, return sample analysis could not be conducted.However, the customer provided the photographs, which showed rsv kit contents were packed in a plastic cover without box.This complaint was confirmed based on the photographic evidence.The root cause could not be identified.Currently, there are no adverse trends identified for labeling / packaging issue.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT
• Common Device Name: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• 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: 17946858
• Report Number: 3006948883-2023-00108
• Device Sequence Number: 20889234
• Product Code: GQG
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2023

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
• Operator of Device: Other
• Device Catalogue Number: 256042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/05/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown