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

Model Number 341002

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

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 prior to use with bd leucocount¿ there was a mix of product.The customer received boxes of products 341001 and 341002, the box of 341002 contained vials for rbc control (same as 341001).The following information was provided by the initial reporter, translated from (b)(6) to english: bd leucocount tm plt control ref 341002 lot lp0321 exp 2021-05-05.Data on tubes inner package: vial 1: bd leucocount tm rbc control high rbc lot lr0321h exp 2021-05-05.Vial 2: bd leucocount tm rbc control low rbc lot lr0321l exp 2021-05-05.Observations and conclusions - looks like a mistake in the packaging of the product.The customer received boxes of products 341001 and 341002 as described.In contrast, box 341002 contained vials for rbc control (same as 341001).

Event Description

It was reported that prior to use with bd leucocount¿ there was a mix of product.The customer received boxes of products 341001 and 341002, the box of 341002 contained vials for rbc control (same as 341001).The following information was provided by the initial reporter, translated from polish to english: bd leucocount tm plt control ref 341002 lot lp0321 exp 2021-05-05.Data on tubes inner package: vial 1: bd leucocount tm rbc control high rbc lot lr0321h exp 2021-05-05.Vial 2: bd leucocount tm rbc control low rbc lot lr0321l exp 2021-05-05.Observations and conclusions - looks like a mistake in the packaging of the product.The customer received boxes of products 341001 and 341002 as described.In contrast, box 341002 contained vials for rbc control (same as 341001).

Manufacturer Narrative

H6: investigation summary the scope of issue is limited to part 341002, lot lp0321.Manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.Complaint trend: there are no complaints related to the reported complaint for the date range between 26mar2020 and 26mar2021.Batch history record (bhr) review: documentation for part 341002, lot lp032 was reviewed.No discrepancies or non-conformances were observed.The materials met all the manufacturing specifications prior to release.Retain sample evaluation / testing: the retain samples for part 341002, lot lp0321 were visually inspected and found unremarkable.The report was not of a product performance issue.Returned sample evaluation: the sample was not requested to be returned because photos were provided.The photos were evaluated and found to support the complaint described.Investigation result / analysis: the investigation was performed by the supplier (#2021-691-1, attached) and the cause assigned to human negligence.Based on the review of complaint trend, defect trend, bhr, root cause and risk analysis, the reported complaint was confirmed.Risk analysis: 10000525149 pfmea, revision 01 was reviewed.Hazard:_missing kit component_____ cause:_operator skipped component when packaging______; harmful effects:_cannot run assay; delay in testing__; severity: _3__; probability: _2__; risk index: _18__ ; new hazard: _no_; mitigation(s) sufficient _yes__.Root cause analysis: based on the investigation result, root cause was determined to be human negligence.Investigation conclusion: based on the investigation result, complaint was confirmed.

• Brand Name: BD LEUCOCOUNT
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11681745
• MDR Text Key: 252941550
• Report Number: 2916837-2021-00181
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903410026
• UDI-Public: 00382903410026
• Combination Product (y/n): N
• PMA/PMN Number: BK000036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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 Expiration Date: 05/05/2021
• Device Model Number: 341002
• Device Catalogue Number: 341002
• Device Lot Number: LP0321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1