MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367296
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set that there was incorrect label information.The following information was provided by the initial reporter: customer problem: error on certificate from regdocs page, wrong lot#.Customer reported an error with the coa for lot#: 2g1781.On the bd website regdocs the coa for this lot# list the lot#: 2f1781.Customer is requesting the correct coa for lot#: 2g1781.Issue product - error on coa.
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.As sekisui is an oem manufacturing site.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: bd was notified regarding an incorrect certificate of authenticity (coa) document on the regdocs site.It was confirmed the incorrect coa document was uploaded for 367296, lot number 2g1781.The customer was provided the correct coa and the regdocs site will be updated.This complaint has been confirmed for the indicated failure mode incorrect coa.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends." h3 other text : see h.10.
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set that there was incorrect label information.The following information was provided by the initial reporter: customer problem: error on certificate from regdocs page, wrong lot#.Customer reported an error with the coa for lot#: 2g1781.On the bd website regdocs the coa for this lot# list the lot#: 2f1781 customer is requesting the correct coa for lot#: 2g1781.Issue product - error on coa.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17607877
• Report Number: 2243072-2023-01489
• Device Sequence Number: 20410076
• Product Code: JKA
• UDI-Device Identifier: 50382903672962
• UDI-Public: 50382903672962
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 07/31/2025
• Device Catalogue Number: 367296
• Device Lot Number: 2G1781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown