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

Model Number LH-0031YN

Device Problems Backflow (1064); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

Patient in outpatient treatment facility for keytruda infusion.Port accessed, flushed without difficulty, however upon aspiration mostly air being drawn back with some saline and blood return noted.No swelling or redness at site, no leaking, patient denied pain upon flush.Port de-accessed and re-accessed with a needle of a different lot number and port flushed without difficulty and brisk blood return; no air aspirated.

• Brand Name: 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: 10975341
• MDR Text Key: 220454481
• Report Number: 10975341
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2020,12/01/2020

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: No Information
• Device Model Number: LH-0031YN
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASEUF018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1