MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD¿ CD2 PE-CY7 CE

Catalog Number 335821

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/10/2022

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 after receipt of bd¿ cd2 pe-cy7 ce that incorrect label information was identified.The following information was provided by the initial reporter: "the customer confirmed the receipt of the replacement of the cd2 pe-cy7 for the pir3005589, however this new lotnumer also has a different clone on the vial then mentioned in the ifu that is provided with the product.As can be seen on the new pictures they send me.So in the past the cd2 pe-cy7 #335821 was always s5.2 clone, now it changed to clone l303.1.".

Manufacturer Narrative

H.6 investigation summary: scope of issue: the scope of issue is limited to cd2 (l303.1) pe-cy¿7 in m/n 335821 lot no.2074553.Problem statement: customer reported clone name suddenly changed on the vial, but also differs from ifu in m/n 335821 lot no.2074553.Manufacturing defect trend: there are no qns related to the reported issue.Date range from 10jun2021 to date 10jun2022 (rolling 12 months).Complaint trend: there are 3 related complaints:.Date ranges from date 10jun2021 to date 10jun2022 (rolling 12 months).Batch history record (bhr) review: batch record 335821-2074553 was reviewed.Batch history record was reviewed.During the manufacturing of m/n 335821 lot no.2074553, the bom called for vial label 23-7300-03 which contains the correct clone l303.1.The bom also called for product insert assembly 23-6188-03.This product insert assembly contains the down revision product insert that contains the clone s5.2 which is the incorrect clone for 335821.Thus, the complaint is confirmed.Retain sample evaluation / testing: retain testing not required since this is not a reagent performance issue.Returned sample evaluation: return sample was not requested since this is not a reagent performance issue.Investigation result / analysis: customer reported clone name suddenly changed on the vial, but also differs from ifu for cd2 (l303.1) pe-cy¿7 in m/n 335821 lot no.2074553.Based on the batch history review, product defect was found.Complaint was confirmed.The bom has been updated with the current release product vial label.This updated vial label references the eifu website to obtain the ifu.Eifu contains the correct clone.This was updated in eco 500000239797.See bom attachment for current label and eifu screenshots exhibiting correct clone.Risk analysis: risk analysis: risk management for material 335821 (100310ra, revision 02) was reviewed.Hazard(s) identified? yes, no? hazard: information hazard.Cause: inadequate instructions provided by bd.Harmful effects: unable to perform testing.Delay in diagnosis.Severity: 3.Probability: 1.Implementation verification: technical datasheet.Effectiveness verification: verified by label approval process.Risk index: 3.Mitigation(s) sufficient yes, no.Root cause analysis: root cause is bom is not updated with the current product insert.Conclusion: based on the investigation result, complaint was confirmed.

Event Description

It was reported that after receipt of bd¿ cd2 pe-cy7 ce that incorrect label information was identified.The following information was provided by the initial reporter: "the customer confirmed the receipt of the replacement of the cd2 pe-cy7 for the pir3005589, however this new lotnumer also has a different clone on the vial then mentioned in the ifu that is provided with the product.As can be seen on the new pictures they send me.So in the past the cd2 pe-cy7 #335821 was always s5.2 clone, now it changed to clone l303.1.".

• Brand Name: BD¿ CD2 PE-CY7 CE
• Type of Device: NA
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14806712
• MDR Text Key: 303296440
• Report Number: 2647876-2022-00163
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/29/2022

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: 03/31/2023
• Device Catalogue Number: 335821
• Device Lot Number: 2074553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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