MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0031

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 12/20/2019

Event Type  malfunction  

Event Description

Port-a-cath line (pac), which was hep-locked, was entered in order to draw scheduled am labs.The line flushed well without resistance and appeared intact at the insertion site.When blood was attempted to be drawn from the line, the syringe filled with air and the line began to leak blood below the clave.The rn clamped the line above the perceived line break and de-accessed the pac.The cvc was re-accessed and blood cultures were drawn prior to drawing labs.Huber needle assembly brought to biomedical for reporting and assessment.Biomedical confirmed line was leaking at the junction where the tubing entered the female luer hub.Bme noted adhesive/sealant may have leaking from bonding point resulting in tubing leak.Line saved for mfg.Evaluation.Manufacturer response for huber needle set, safestep (per site reporter).Awaiting mfg response.

• Brand Name: SAFESTEP PORT ACCESS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 9523425
• MDR Text Key: 172840178
• Report Number: 9523425
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH-0031
• Device Catalogue Number: LH-0031
• Device Lot Number: ASDV051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA