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

Model Number	337166
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the ifu was missing from packaging of bd multitest¿.The following information was provided by the initial reporter, translated from german to english: the customer got the new lot of the reagent and the ifu were missing in the package.Only a note about storage conditions was inside.
Additional Manufacturer Narrative
H.6.Investigation: scope of issue: the scope of issue is limited to part 337166 lot 30559.Problem statement: customer reported complaint on 18-jun-2021, that that the instructions for use document (ifu) was missing from the kit, part 337166 lot 30559.Manufacturing defect trend: there are no quality notifications (qn-zm) for material 337166 related to the reported issue.Date range (incident to 12 months back) is from 18-jun-2020 to 18-jun-2021.Root cause analysis: based on the investigation result, root cause was not determined.Complaint history review: there is only one complaint related to the reported complaint, it is this complaint.Date range is from 18-jun-2020 to 18-jun-2021.Risk review: process failure mode effects analysis (pfmea) 10000525149 rev.01.Risk mitigation is sufficient.Hazard(s) identified? yes.Hazard #: not numbered; hazard : missing datasheet; cause: operator skipped box or component when packaging.Harmful effects: cannot run assay.Delay in testing.Severity:_3; probability: 2; risk index: 18; implementation: ms defines components.Risk control: pr003: 100% inspection of packaged product.Effectiveness verification: not applicable.New hazard: no.Mitigation(s) sufficient: yes.Batch history record (bhr) review: bhr for part 337166 lot 30559 was reviewed.The materials met all the manufacturing specifications prior to release.Ms337166 rev.10 shows that each kit contains one ifu and the number of ifu used equals the number of kits made.The inspection report dated 07-jan-2021 indicates that the required insert (including ifu) was present.Returned sample analysis: a return sample is not requested because a photo of an opened kit would not indicate if the ifu was present when the kit left bd.A photo is not requested because a photo of an opened kit would not indicate if the ifu was present when the kit left bd.Retain sample analysis: a sample of the retained kit, part 337166 lot 30559, was inspected.The defect was not present: the instructions for use were correctly placed.Conclusion: based on the investigation result, complaint was not confirmed.H3 other text : see h.10.
Event or Problem Description
It was reported that the ifu was missing from packaging of bd multitest¿.The following information was provided by the initial reporter, translated from german to english: the customer got the new lot of the reagent and the ifu were missing in the package.Only a note about storage conditions was inside.

• Brand Name: BD MULTITEST
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 12162508
• Report Number: 2916837-2021-00307
• Device Sequence Number: 3577530
• Product Code: GKZ
• UDI-Device Identifier: 00382903371662
• UDI-Public: 00382903371662
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 337166
• Device Catalogue Number: 337166
• Device Lot Number: 30559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1