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 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: 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 the bd facs¿ clean solution that the label was incorrect.The following information was provided by the initial reporter: the sodium hypochlorite (naocl) concentration printed on the carton of facsclean is different from that on sds.On (b)(6) 2022, bdj¿s sales rep.Received an email from the customer, with the question ¿the sodium hypochlorite (naocl) concentration on the facsclean carton and in the training manual is different, and which is correct?¿ requesting the customer to provide the photo of the relevant carton showing the concentration, bdj¿s sales replied that 1% is correct because there is the description of 1% in the us issued sds.On (b)(6).Bdj¿s sales rep.Received a photo and confirmed the description of naocl 15%.Bdj¿s sales rep.Also confirmed that this was made in poland, and then checked the sds from poland, which contained the description of 1-2.5%.The naocl concentration the customer pointed out was also different from that on poland sds.A photo is attached in "attachment's.".

Event Description

It was reported that while using the bd facs¿ clean solution that the label was incorrect.The following information was provided by the initial reporter: the sodium hypochlorite (naocl) concentration printed on the carton of facsclean is different from that on sds.On 12/21/2022, bdj¿s sales rep.Received an email from the customer, with the question ¿the sodium hypochlorite (naocl) concentration on the facsclean carton and in the training manual is different, and which is correct?¿ requesting the customer to provide the photo of the relevant carton showing the concentration, bdj¿s sales replied that 1% is correct because there is the description of 1% in the us issued sds.On 12/22, bdj¿s sales rep.Received a photo and confirmed the description of naocl 15%.Bdj¿s sales rep.Also confirmed that this was made in poland, and then checked the sds from poland, which contained the description of 1-2.5%.The naocl concentration the customer pointed out was also different from that on poland sds.A photo is attached in "attachment(s).".

Manufacturer Narrative

H.6 investigation summary scope of issue: solution part#: 340345, bd facs clean solution 5l, lot 2104009814.Problem statement: customer noted that the sodium hypochlorite(naocl) concentration printed on the carton of facsclean is different from the sds.Manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.Batch history record (bhr) review: bhr part 340345 lot 2104009814 was reviewed.The materials met all the manufacturing specifications prior to release.Complaint trend: there are 0 similar complaints other than this complaint (b)(4) that was found.Date range from 21dec21 to 21dec22.Retain sample evaluation/testing: the retained samples for part 340345 were visually inspected and it contains the same hypochlorite concentration described in the complaint.Returned sample evaluation: there is no sample returned.Images are provided by the customer.Investigation analysis: the investigation was performed and based on the review of complaint trend, defect trend, bhr, customer supplied images, and risk analysis.The supplier was interviewed to understand the root cause.They confirmed that there is no formulation change.Back in april 2021, bd initiated the label update from displaying the ingredients naoci with explaining there is 0.1% ci inside the naoci to chlorine %.The product materials/component list and the certificate of analysis /conformity were also reviewed to confirm the ingredients.See attachment label investigation summary and supplier communication.Risk analysis ¿ · 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.This incident represents no added risk to the user or results.Risk management file part 10000492933, ra bd facsflow sheath fluid, revision 02 was reviewed.This is a risk file applies to all sheath fluid.Hazard(s) identified? yes hazard id#: 4.1.Hazard: information hazard.Cause: _inadequate instructions or confusing information provided by bd harmful effects: delay in sample acquisition.Residual severity: 2.Residual probability: 1.Residual risk index: 2.Potential cause: based on the investigation result, potential cause was determined to be bd initiated the label update for due to regulatory requirements, but there is no change with ingredients.Conclusion: based on the investigation result, the complaint cannot be confirmed.

• 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: 16052333
• MDR Text Key: 306978631
• Report Number: 2916837-2022-00373
• Device Sequence Number: 1
• Product Code: PPM
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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: 08/09/2022
• Device Catalogue Number: 340345
• Device Lot Number: 2104009814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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