MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368652
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
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that prior to use with bd vacutainer® safety-lok¿ blood collection set with pre-attached holder it was discovered that the ifu for the device does not comply with ukrainian requirements.The following information was provided by the initial reporter: 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 ukrainian conformity mark: ukrainian conformity mark with conformity assessment body number: as an example please see below the new ifu for sku 367300 which was registered via conformity assessment body ¿ there is no ukrainian conformity assessment body number underneath the ukrainian conformity mark while it should be included.This is considered as non-conformity.Also, we would like to point out that in the procedure ¿medical device and in vitro diagnostic medical device required labeling content¿ (please find enclosed attachment#3.) used by the labeling team this requirement is not captured.Therefore, the sop also needs to be updated and implemented.
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 that prior to use with bd vacutainer® safety-lok¿ blood collection set with pre-attached holder it was discovered that the ifu for the device does not comply with ukrainian requirements.The following information was provided by the initial reporter: 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 ukrainian conformity mark: ukrainian conformity mark with conformity assessment body number: as an example please see below the new ifu for sku 367300 which was registered via conformity assessment body ¿ there is no ukrainian conformity assessment body number underneath the ukrainian conformity mark while it should be included.This is considered as non-conformity.Also, we would like to point out that in the procedure ¿medical device and in vitro diagnostic medical device required labeling content¿ (please find enclosed attachment#3.) used by the labeling team this requirement is not captured.Therefore, the sop also needs to be updated and implemented.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17000056
• Report Number: 1024879-2023-00328
• Device Sequence Number: 16754480
• Product Code: JKA
• UDI-Device Identifier: 50382903686525
• UDI-Public: (01)50382903686525
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K991088
• 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: 368652
• Device Catalogue Number: 368652
• 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