MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	366703
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® no additive (z) tubes that there was foreign matter in tube; biological and non-biological in three different tubes.The following information was provided by the initial reporter: customer is reporting foreign matter.Affected lot numbers 3048751, 2227106, and 3111788.
Additional Manufacturer Narrative
E.6 initial reporter e-mail: (b)(6).There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 3048751, d4.Medical device expiration date: 2024-08-31, h4.Device manufacture date: 2023-02-17.D4.Medical device lot #: 2227106, d4.Medical device expiration date: 2024-02-29, h4.Device manufacture date: 2022-08-15.D4.Medical device lot #: 3111788, d4.Medical device expiration date: 2024-10-31, h4.Device manufacture date: 2023-04-21.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
B.1 date of event was updated to 21jul2023.The following lots are being taken out of previously submitted report 1917413-2023-00768, these lots occurred at separate locations and require their own complaint.D4.Medical device lot #: 3111788; d4.Medical device expiration date: 2024-10-31; h4.Device manufacture date: 2023-04-21.D4.Medical device lot #: 3048751; d4.Medical device expiration date: 2024-08-31; h4.Device manufacture date: 2023-02-17.H.6 investigation summary: material #: 366703; lot/batch #: 2227106.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for embedded foreign matter was observed.Embedded fm is, by its nature, isolated from any specimen.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode embedded foreign matter.Bd was not able to identify a root cause for the indicated failure mode.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.
Event or Problem Description
It was reported that while using bd vacutainer® no additive (z) tubes that there was foreign matter in tube; biological and non-biological in three different tubes.The following information was provided by the initial reporter: customer is reporting foreign matter.Affected lot numbers 3048751, 2227106, and 3111788.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17500105
• Report Number: 1917413-2023-00768
• Device Sequence Number: 12360343
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 10/31/2024
• Device Catalogue Number: 366703
• Device Lot Number: SEE H.10
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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