MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	364943
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis transfer straw kit customer they only received the straw but not the conical tube.No patient impacted.The following information was provided by the initial reporter.The customer stated: customer problem: customer is reporting they only received the straw but not the conical tube.Affected lot number 3062535.
Additional Manufacturer Narrative
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® urinalysis transfer straw kit customer they only received the straw but not the conical tube.No patient impacted.The following information was provided by the initial reporter.The customer stated: customer problem: customer is reporting they only received the straw but not the conical tube.Affected lot number 3062535.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 2 photos were provided by your facility for investigation.The photos were evaluated and the indicated failure mode for empty packaging with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.

• Brand Name: BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18100273
• Report Number: 1917413-2023-01129
• Device Sequence Number: 15356482
• Product Code: JTW
• UDI-Device Identifier: 50382903649438
• UDI-Public: (01)50382903649438
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K790366
• 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): 11/14/2023

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: 08/31/2024
• Device Catalogue Number: 364943
• Device Lot Number: 3062535
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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