MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD RETIC-COUNT; COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Model Number	349204
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the packaging was leaking and products label information was erased with bd retic-count¿.There was no user impact.The following information was provided by the initial reporter, translated from (b)(6) to english: (1 of 2 complaints) on the other hand, upon receipt, we noticed that the product was leaking despite the packaging precautions.The previous batch was also leaking.Moreover, each time, the label is completely erased.This product is likely to be carcinogenic (see data sheet), and with this problem of leakage, we put some everywhere on the gloves, the mat.Could you please forward our remarks to the competent service in order to guarantee a better safety of the users.We did not come into contact with the product without protective equipment, we always handled it with gloves.However, the bench was contaminated and we decontaminated it with activated carbon.Can you confirm that this product is indeed carcinogenic?.
Event or Problem Description
It was reported that the packaging was leaking and products label information was erased with bd retic-count¿.There was no user impact.The following information was provided by the initial reporter, translated from french to english: (1 of 2 complaints) on the other hand, upon receipt, we noticed that the product was leaking despite the packaging precautions.The previous batch was also leaking.Moreover, each time, the label is completely erased.This product is likely to be carcinogenic (see data sheet), and with this problem of leakage, we put some everywhere on the gloves, the mat.Could you please forward our remarks to the competent service in order to guarantee a better safety of the users.- we did not come into contact with the product without protective equipment, we always handled it with gloves.However, the bench was contaminated and we decontaminated it with activated carbon.Can you confirm that this product is indeed carcinogenic?.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00316 was sent in error.The reported issue was that the vial was leaking, therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD RETIC-COUNT
• Common Device Name: COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 12197522
• Report Number: 2916837-2021-00316
• Device Sequence Number: 11136513
• Product Code: GKL
• UDI-Device Identifier: 00382903492046
• UDI-Public: 00382903492046
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880360
• 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): 09/24/2021

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: 349204
• Device Catalogue Number: 349204
• Device Lot Number: 1049150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1