MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Model Number	366703
Medical Device Problem Codes	Component Missing (2306); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd vacutainer® no additive (z) tubes that there was missing additive.The following information was provided by the initial reporter: customer reports the no additive tube is clotting within 30 min after blood collection.Not allowing pipetting.
Additional Manufacturer Narrative
E.7: initial reporter (b)(6).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
After further evaluation of the complaint, it has been determined that the previously submitted report 2243072-2023-00934 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using the bd vacutainer® no additive (z) tubes that there was missing additive.The following information was provided by the initial reporter: customer reports the no additive tube is clotting within 30 min after blood collection.Not allowing pipetting.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17035456
• Report Number: 2243072-2023-00934
• Device Sequence Number: 20431410
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 366703
• Device Catalogue Number: 366703
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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