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

Model Number	367323
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "complaint: non-compliance of the labeling for bd products shipped to ukraine (labeling not compliant with local/ukrainian requirements) affected bd products: ids sm with the list of affected skus identified by our team) we discovered that some of the ifus for ids sm products are not compliant with ukrainian requirements.Ids sm products of higher classes were registered via conformity assessment body in ukraine.When product is registered via conformity assessment body it is required to have it indicated on the labels and ifus (conformity assessment body number must be placed on the labeling) ¿ it must be placed underneath the ukrainian conformity mark.".
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.It was determined by management that this is not a product complaint, therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "complaint: non-compliance of the labeling for bd products shipped to ukraine (labeling not compliant with local/ukrainian requirements) affected bd products: ids sm with the list of affected skus identified by our team) we discovered that some of the ifus for ids sm products are not compliant with ukrainian requirements.Ids sm products of higher classes were registered via conformity assessment body in ukraine.When product is registered via conformity assessment body it is required to have it indicated on the labels and ifus (conformity assessment body number must be placed on the labeling) it must be placed underneath the ukrainian conformity mark.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17000002
• Report Number: 2243072-2023-00878
• Device Sequence Number: 6724034
• Product Code: JKA
• UDI-Device Identifier: 50382903673235
• UDI-Public: 50382903673235
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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 Model Number: 367323
• Device Catalogue Number: 367288
• Device Lot Number: UNKNOWN
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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