MAUDE Adverse Event Report: BD BD; BD PHASEAL INJECTOR LUER LOCK N35

Model Number 515003

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/05/2018

Event Type  Injury  

Event Description

There have been multiple instances where product comes apart while in use, leading to bleeding from site.Unable to identify a user error.Believe this is a product problem.Mfr rep has been made aware.Product is bd phaseal injector luer lock n35.Product #515003, lot #1803107 and exp 08/31/2020.

• Brand Name: BD
• Type of Device: BD PHASEAL INJECTOR LUER LOCK N35
• Manufacturer (Section D): BD
• MDR Report Key: 7872578
• MDR Text Key: 120319979
• Report Number: MW5079774
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/11/2018

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: 08/31/2020
• Device Model Number: 515003
• Device Catalogue Number: 515003
• Device Lot Number: 1803107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA