MAUDE Adverse Event Report: BARD, INC POWERGLIDE® MIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number POWERGLIDE® MIDLINE CATHETER

Device Problems Bent (1059); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 08/25/2017

Event Type  malfunction  

Event Description

Vat nurse called to evaluate patient for iv access.Upon inserting a power glide, this nurse noted something firm with insertion.A bend in the catheter was noted with ultrasound evaluation and the catheter was withdrawn.With further evaluation, it was seen that there was a small piece of catheter remaining in the vein upon ultrasound and the piece missing from the top of the catheter.Dr.Was notified and the patient sent to ir for retrieval.Patient was educated regarding the situation and process.

• Brand Name: POWERGLIDE® MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD, INC; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 6935421
• MDR Text Key: 88824357
• Report Number: 6935421
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 09/11/2017

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: POWERGLIDE® MIDLINE CATHETER
• Device Catalogue Number: NOT KNOWN
• Device Lot Number: NOT KNOWN
• Other Device ID Number: 10CM
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR