MAUDE Adverse Event Report: C. R. BARD INC. HICKMAN DOUBLE LUMEN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Event Description

While obtaining lab work from white lumen, flushing easily with saline no resistance lumen just teared ,area clamped doctor notified , pedi surg called and nurse practitioner came up to examine and repaired lumen.While flushing line slowly just teared.Ehr review finds detailed documentation of event and no patient harm.

• Brand Name: HICKMAN DOUBLE LUMEN
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD INC.; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 7361544
• MDR Text Key: 103188712
• Report Number: 7361544
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2018,03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR