MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 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 11/11/2021

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 have been found during a field corrective action anti-kappa pe ce contamination with cd8 pe antibody.

Manufacturer Narrative

H.6 investigation summary: scope of issue: the scope of issue is limited to catalogue no.Material 347246 batch 1153851, anti kappa pe.Problem statement: customer reported a claim for material 347246 batch 1153851 referencing field corrective action(fca) bdb-22-4384 for anti kappa contamination with cd8 pe.The customer checked analysis performed with this product and confirmed described contamination for analyzed patient samples, but without impact on patient diagnosis and treatment.Manufacturing defect trend: the manufacture trend defect was evaluated for material 347246 in the period of 29jul2022 to 29jul2021 and there is no reported quality notifications for the material in the timeframe evaluated.Batch history record (bhr) review: the bhrs for material 347246 batch 1153851 were evaluated as part of the investigation conducted under bdb-22-4384 and found that the cleaning of a vessel was not documented at the purification phase.Complaint history review: there are two complaints reported for material 347246 after the fca was initiated.Additional claims were evaluated as part of the investigation conducted under bdb-22-4384-sa for other listed catalogue numbers.Retain sample analysis: the retained sample was evaluated as part of the investigation conducted for fca bdb-22-4384 and confirm the event reported on the fca.Returned sample analysis: the sample was not returned but the manufacturing site retained bulk sample was evaluated.Labeling /packaging review: n/a.Risk review: fmea anti-kappa revision 3 was reviewed.Hazard(s) identified? yes, section 2: not perform to spec/claim.Potential function failure: section 2: not perform to spec/claim.Potential effect of failure: 3.Wrong result.¿ no matching profile.-customer inconveniences -additional testing, cost and time.Potential cause of failure: 10.Chemistry bulk contamination with another reagent.Severity: 7.Occurrence : 1.Detection : 8.Risk control: 1.Column stripping procedures, 2.Process segregation.3.Use of clean apparatus - validated washing processes.4.Physical testing in qc ref vs test.Rpn:56 rpn < 90 will be acceptable.New hazard: none.Mitigation(s) sufficient x: yes / no.The risk was analyzed as part of the bdb-22-4384 -hra and a field action initiated.Root cause analysis: based on the investigation result, root cause was the use of an uncleaned vessel at the purification stage.Conclusion: based on the investigation result, complaint was confirmed and the customer was notified as part of the actions taken under field corrective action bdb-22-4384.

Event Description

It was reported that have been found during a field corrective action anti-kappa pe ce contamination with cd8 pe antibody.

• Brand Name: ANTI-KAPPA PE CE
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; 10865 road to the cure; suite no. 210; san diego CA 92121
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; 10865 road to the cure; suite no. 210; san diego CA 92121
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15196036
• MDR Text Key: 304974407
• Report Number: 3007886372-2022-00002
• 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: 11/23/2022

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: 1153851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2021
• 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