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

Model Number LH-0031

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Reflux within Device (1522)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

Patient was at home with continuous blina infusing.Mom noticed blood backing up into the line and noticed some leaking at the connection site.Once in the clinic and port needle was de-accessed, rn flushed needle and noticed saline squirting out of a hole near the plastic safety device of the needle.Patient had a delay in receiving his continuous infusion and had to experience another port needle access.

• Brand Name: SAFESTEP
• 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: 11527105
• MDR Text Key: 241002812
• Report Number: 11527105
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2021,02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LH-0031
• Device Catalogue Number: LH-0031
• Device Lot Number: ASEYF005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Event Location: Home
• Date Report to Manufacturer: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Weight: 16