MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. HOHN CATHETER FOR CENTRAL VENOUS PLACEMENT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

Upon removing the vancomycin lock from the white lumen of the patient's central line, the blood return was sluggish.I got 4mls of blood out, and then proceeded to flush the lumen.While flushing the lumen, it burst and the saline sprayed out.The line was immediately clamped, and the provider was paged.There was a small hole in the lumen, so it ended up being removed.

• Brand Name: HOHN CATHETER FOR CENTRAL VENOUS PLACEMENT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 15893251
• MDR Text Key: 304620754
• Report Number: 15893251
• Device Sequence Number: 1
• Product Code: LJS
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male