MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POLY MIDLINE CATHETER

Device Problems Stretched (1601); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Event Description

When rn was pulling back the stylet/wire inside the midline catheter to line them up together, she noticed the wire she was pulling was longer than what it usually is and both were not lining up as they should.The wire appeared to have "stretched out" and part of it had split in two.

• Brand Name: BARD POLY MIDLINE CATHETER
• Type of Device: BARD POLY MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; 605 north ; 5600 west; salt lake city UT 84116
• MDR Report Key: 5595034
• MDR Text Key: 43325113
• Report Number: 5595034
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2016
• Distributor Facility Aware Date: 02/22/2016
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR