MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY MULTIPLE SAMPLE LEUR ADAPTER BD VACUTAINER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367290

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2022

Event Type  Injury  

Event Description

Pt received hemodialysis and required routine blood draw.The lab specimen is obtained by using the vacutainer with a leur adapter attached to the pt's fistula needle.After the specimen was obtained, the vacutainer with the leur adapter was removed from the pt's fistula needle.During the removal process, the tip of the leur adapter broke inside the tubing of pt's fistula needle.Pt refused to have the needle re-inserted.The fistula needle with the broken tip was removed from the pt's arm.Pt's catheter was used in place of arteriovenous fistula for the treatment.

• Brand Name: MULTIPLE SAMPLE LEUR ADAPTER BD VACUTAINER
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ
• MDR Report Key: 14885277
• MDR Text Key: 295260038
• Report Number: MW5110630
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367290
• Device Catalogue Number: 367290
• Device Lot Number: 1333247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian