MAUDE Adverse Event Report: BECTON, DICKINSON, AND COMPANY BD VACUTAINER URINE COLLECTION STRAW KIT; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLE

Lot Number 0343537

Device Problems Component Missing (2306); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

Bd vacutainer - c&s transfer straw kit defect, missing protective needle cap.Specific incident type: contact with sharps.Level of harm: none, defect was caught prior to use.Bd vacutainer - c&s transfer straw kit.Situation: transfer device package had defective item within the prepackaged kit.The defective item was the transfer device which had exposed needle without protective cap.

• Brand Name: BD VACUTAINER URINE COLLECTION STRAW KIT
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLE
• Manufacturer (Section D): BECTON, DICKINSON, AND COMPANY; 1 becton drive; franklin lakes NJ 07417 1815
• MDR Report Key: 12173286
• MDR Text Key: 261940734
• Report Number: MW5102554
• Device Sequence Number: 1
• Product Code: JKA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/13/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Lot Number: 0343537
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR