MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD¿ STEM CELL ENUMERATION; COUNTER, DIFFERENTIAL CELL

Model Number	344563
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ stem cell enumeration was missing lot info on the packaging.The following information was provided by the initial reporter: it was reported by the customer that 344563_1285770_ missing lot no on the kit box.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: scope of issue: the scope of issue is limited to part 344563 lot 1285770, stem cell enumeration kit (b)(4) tests.Problem statement: customer reported complaint on 20-dec-2021, kit box did not show lot number and expiration date.This happened on one qty and three qty were fine.Manufacturing defect trend: there are no quality notifications (qn-zm) for part 344563 related to the reported issue.Date range (date opened to 12 months back) is from 21-dec-2020 to 21-dec-2021.Root cause analysis: based on the investigation result, root cause was application of a label on the kit box that had not received lot specific data.Visual inspection also failed.Complaint history review: there is one complaint for this issue in part 344563, it is this complaint, parent (b)(4).Date range is from 21-dec-2020 to 21-dec-2021.Risk review: process failure mode effects analysis (pfmea) 10000525149 rev.01.Risk mitigation is sufficient.Hazard(s) identified? yes.Hazard #: not numbered; hazard : label has incomplete or illegible information; cause: dirty or worn print head, printer setup; harmful effects: wrong assay result or cannot run assay.Delay in testing.; severity:_7; probability: 2; risk index: 42; implementation: validated printers; risk control: pr003: visual inspection.Sample labels are attached to batch record.Effectiveness verification: not applicable; new hazard: no.; mitigation(s) sufficient: yes; batch history record (bhr) review: bhr for part 344563 lot 1285770 was reviewed.The materials met all the manufacturing specifications prior to release.Wi7197-03 rev.03 includes 6 copies of the kit label and those copies have correct lot number and expiration date.An inspection report dated 21-oct-2021 finds that the label has correct lot number and expiration date.Returned sample analysis: a photo is not requested because the provided powerpoint document with photos confirms the complaint.The provided powerpoint document shows 2 photos, one of a kit-box missing the required lot number and expiration date and barcodes, and one of a kit-box with the required marks.Retain sample analysis: from the retained sample of part 344563 lot 1285770, the kit label was inspected and the defect was not present.The correct lot number and expiration date were present.Labeling /packaging review: part 344563 lot 1285770 was reviewed.The materials met all the labeling / packaging specifications prior to release.Conclusion: based on the investigation result, complaint is confirmed.
Event or Problem Description
It was reported that the bd¿ stem cell enumeration was missing lot info on the packaging.The following information was provided by the initial reporter: it was reported by the customer that 344563_1285770_ missing lot no on the kit box.

• Brand Name: BD¿ STEM CELL ENUMERATION
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: 13252992
• Report Number: 2916837-2021-00522
• Device Sequence Number: 14600798
• Product Code: GKZ
• UDI-Device Identifier: 00382903445639
• UDI-Public: 00382903445639
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK110037
• 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): 03/11/2022

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 Expiration Date: 08/31/2023
• Device Model Number: 344563
• Device Catalogue Number: 344563
• Device Lot Number: 1285770
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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