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

Model Number 340911

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

Date of event: unknown.The date received by manufacturer has been used for this field.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 when opening bd¿ multi-check package, the product listed was part # 557940.The following information was provided by the initial reporter, translated from (b)(6) to english: when opening the package, the reference 557940 was in it.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 2916837-2021-00182 was sent in error.It was discovered that the issue was a shipping/packaging issue and therefore, is not considered to be a reportable malfunction.

Event Description

It was reported that when opening bd¿ multi-check package, the product listed was part # 557940.The following information was provided by the initial reporter, translated from french to english: when opening the package, the reference 557940 was in it.

• Brand Name: BD MULTI-CHECK
• 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: 11681900
• MDR Text Key: 252904151
• Report Number: 2916837-2021-00182
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903409112
• UDI-Public: 00382903409112
• Combination Product (y/n): N
• PMA/PMN Number: K961610
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/02/2021
• Device Model Number: 340911
• Device Catalogue Number: 340911
• Device Lot Number: BM0421N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1