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 04/14/2022

Event Type  malfunction  

Event Description

It was reported that upon receipt of bd¿ cd2 pe-cy7 ce that incorrect label information was identified.The following information was provided by the initial reporter: "clone name suddenly changed on the vial, but also differs from ifu.Customer is very surprised in the past the #335821 was the clone s5.2 now it suddenly changed to the l303.1, how can this be? the ifu still states the s5.2 clone, but the product label doesn't! so old 335821 is lot number 1067111 is clone s5.2, latest 335821 is lot number 1350866 and has the changed clone l303.1.This is very strange! see extra photo's with the details! we have recently ordered the cd2 pe-cy7, previously it was always clone s5.2 article no 335821 (this is also still on the jar we are using now).Now we have received: cd2 pe-cy7 clone l303.1 but the package insert is from clone s5.2.The article number on this jar with the other clone is also 335821, the same as the package leaflet of s5.2.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with additional information: d9: device available for eval? yes.H2: device return to manuf.?: no.H2: device eval by manufacturer?: yes.Scope of issue: the scope of issue is limited to cd2 (l303.1) pe-cy¿7 in m/n 335821 lot no.1350866.Problem statement: 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.1350866.Manufacturing defect trend: there are no qns related to the reported issue.Date range from 14apr2021 to date 14apr2022 (rolling 12 months).Complaint trend: there are 2 related complaints.Date ranges from date 14apr2021 to date 14apr2022 (rolling 12 months).Batch history record (bhr) review: batch record 335821-1350866 was reviewed.Batch history record was reviewed.During the manufacturing of m/n 335821 lot no.1350866, 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.1350866.Based on the batch history review, product defect was found.Complaint was confirmed.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 upon receipt of bd¿ cd2 pe-cy7 ce that incorrect label information was identified.The following information was provided by the initial reporter: "clone name suddenly changed on the vial, but also differs from ifu customer is very surprised in the past the #335821 was the clone s5.2 now it suddenly changed to the l303.1, how can this be? the ifu still states the s5.2 clone, but the product label doesn't! so old 335821 is lotnumber 1067111 is clone s5.2, latest 335821 is lotnumber 1350866 and has the changed clone l303.1.This is very strange! see extra photo's with the details! we have recently ordered the cd2 pe-cy7, previously it was always clone s5.2 article no 335821 (this is also still on the jar we are using now) now we have received: cd2 pe-cy7 clone l303.1 but the package insert is from clone s5.2 the article number on this jar with the other clone is also 335821, the same as the package leaflet of s5.2.".

• 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: 14739508
• MDR Text Key: 302182527
• Report Number: 2647876-2022-00161
• 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: 07/27/2022

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: 12/31/2022
• Device Catalogue Number: 335821
• Device Lot Number: 1350866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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