MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES ANTI-KAPPA PE CE

Catalog Number 347246

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using anti-kappa pe ce, user discovered contamination.The following information was provided by the customer: found due to field corrective action emea bdb-22-4384a anti kappa contamination with cd8 pe antibody.Due to fca customer checked analysis performed with this product.Confirmed described contamination for analyzed patient samples, but without impact on patient diagnosis and treatment.

Event Description

It twas reported that while using anti-kappa pe ce user discovered contamination.The following information was provided by the customer: found due to field corrective action emea bdb-22-4384a anti kappa contamination with cd8 pe antibody.Due to fca customer checked analysis performed with this product.Confirmed described contamination for analyzed patient samples, but without impact on patient diagnosis and treatment.

Manufacturer Narrative

H6 investigation summary: bd acknowledges the customer¿s experience regarding the indicated failure mode of contamination with the reported reagent material # 347246 batch 1284407.A review of the manufacturing records was completed for the reagent.The claim was confirmed and communicated as part of field corrective action bdb-22-4384 fa for anti kappa contamination with cd8 pe and actions taken as part of capa4453779.Bd is continually monitoring complaints received for this device and reported issues to identify emerging trends.

• Brand Name: ANTI-KAPPA PE CE
• Type of Device: NA
• 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: 15253715
• MDR Text Key: 301292641
• Report Number: 2916837-2022-00223
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

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
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 347246
• Device Lot Number: 1284407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1