MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ CLEAN SOLUTION; GENERAL PURPOSE

Catalog Number 340345

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

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 facs¿ clean solution, there was incorrect label information noticed.The following information was provided by the initial reporter that the label information was incorrect.As can be seen in the attached photo, printed information on the lot number and the expiration date on the shelf carton has been replaced by each other.

Event Description

It was reported that while using bd facs¿ clean solution, there was incorrect label information noticed.The following information was provided by the initial reporter that the label information was incorrect.As seen in the photo, printed information on the lot number and the expiration date on the shelf carton has been replaced by each other.

Manufacturer Narrative

H.6 investigation summary: (b)(4).Scope of issue: solution part#: 340345, bd facsclean 5l, lot # 2201409824.Problem statement: customer reported that they received a solution with lot and expiration date swapped around in the product label.Manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.Batch history record (bhr) review: batch production record for product was reviewed by the supplier.The materials met all the manufacturing specifications prior to release, and no deviations were reported.Complaint trend: there is 1 similar complaints, other than this complaint that was found.Date range from 8aug21 to 8aug22.Retain sample evaluation/testing: supplier has reviewed their retain sample, and identified impacted lots with labels.Returned sample evaluation: there is no sample returned, photo of label were provided and attached in the complaint.Investigation and root cause analysis: per supplier¿s note, as part of the investigation, they reviewed their process of printing labels and label management.They noted in 2021, there were changes made to the template of labels applied to bd products.In addition, their printing system has also changed.However, the interface between their erp system and the printing system was validated, hence there is no errors in the data transmission between the systems.Hence, the likely root cause of this complaint was the use of incorrect templates for printing labels.Impacted lots number were identified and communicated with bd quality.The supplier is in progress of implementing corrective action for this issue.Risk analysis ¿ this solution is a general purpose ivd class i product, which is an ancillary to the flow cytometer.It is not a component of the reagent or stained sample solution; it is not used in conjunction with cytometric data acquisition.In additional, supplier confirmed there is no missing information on the label, the correct labeling information was located in a different location within the same label.This incident represents no added risk to the user or results.Severity: s1, occurrence: o2, risk level: low.Conclusion: based on the investigation result, the complaint is confirmed.Root cause: based on the investigation result, the complaint root cause is confirmed by the supplier.The supplier has implemented the corrective action for this issue.

• Brand Name: BD FACS¿ CLEAN SOLUTION
• Type of Device: GENERAL PURPOSE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15312802
• MDR Text Key: 300871894
• Report Number: 2916837-2022-00232
• Device Sequence Number: 1
• Product Code: PPM
• UDI-Device Identifier: 00382903403455
• UDI-Public: 0100382903403455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 01/30/2023

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
• Device Operator: Other
• Device Expiration Date: 07/14/2023
• Device Catalogue Number: 340345
• Device Lot Number: 2201409824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1