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 Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the label incorrectly states the concentration is 15% with bd facs¿ clean solution.The following information was provided by the initial reporter, translated from (b)(6) to english: according to the customer¿s report, the naocl (naclo) concentration of facs clean is 1% but the label on the carton states the concentration of 15%.

Event Description

It was reported that the label incorrectly states the concentration is 15% with bd facs¿ clean solution.The following information was provided by the initial reporter, translated from japanese to english: according to the customer¿s report, the naocl (naclo) concentration of facs clean is 1% but the label on the carton states the concentration of 15%.

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of this issue is limited to 340345 and all lots since it has to do with the label.Problem statement: the label states naocl (naclo) concentration of facs clean is 1% but the label on the carton states the concentration of 15%.Manufacturing defect trend: this product is manufactured by a supplier, so bd does not have the trend data.Complaint trend: this is only complaint (pr2295455) related to the reported complaint over the period from 14 jan 2020 to 14 jan 2021.Batch history record (bhr) review: this product is manufactured by a supplier, so bd does not have the bhr.Retain sample evaluation / testing: retains is not required since this is related to a label issue and not a functional/performance issue.Returned sample evaluation: none received, but label can be reviewed via label specification and label picture provided by the customer.Investigation result / analysis: bdb quality initiated an investigation on the customer complaint regarding the information on the facsclean label.Pictures and label specification were reviewed.The information on the label is confusing the 0.1% cl of a stock solution of 15% naocl is contained in facsclean.The label has been corrected to state the right amount of cl and the new label was released on 22 mar 2021.Risk analysis: there is no risk to customer or patients since the solution formulation was not changed.Any chemical/safety information can be found in the sds.Root cause analysis: a possible root cause could be the interpretation of the information by the originator and approvers when the label was updated in 2016.Conclusion: complaint is confirmed and the label is updated.See h10.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00045 was sent in error.This complaint is not mdr reportable."per cfr regulation 809.3.This device is not considered an ivd used for clinical diagnosis and is therefore exempt from mdr reporting.However, in the event serious injury does occur, this will be filed per the cfr 803 regulations.The complaint has been entered into our tracking system and will be investigated, tracked and trended." the event type associated with this complaint is being used with an instrument/ reagent that is for "research use only (ruo)".

Event Description

It was reported that the label incorrectly states the concentration is 15% with bd facs¿ clean solution.The following information was provided by the initial reporter, translated from japanese to english: according to the customer¿s report, the naocl (naclo) concentration of facs clean is 1% but the label on the carton states the concentration of 15%.

• 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
• MDR Report Key: 11296700
• MDR Text Key: 256078313
• Report Number: 2916837-2021-00045
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2021

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 Catalogue Number: 340345
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/08/2021; 04/20/2021
• Supplement Dates FDA Received: 04/08/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1