MAUDE Adverse Event Report: CR BARD POWER GLIDE (18G/18CM); MIDLINE

Lot Number RECP1311

Device Problems Occlusion Within Device (1423); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  Injury  

Event Description

Power glide (18g/8cm) inserted on (b)(6) 2018.By (b)(6) 2018 catheter clogged, unusable and removed.This is when rn noted wire in the actual catheter.This caused the line to clot off.X-ray done to make sure a piece of wire had not dislodged and gone into patient.Power glide inserted on (b)(6) 2018 and removed on (b)(6) 2018.The power glide was being used for a couple of days before it clotted off.Once the catheter was removed, it was noted that a portion of the wire remained in the catheter and had not fully retracted into the insertion/launching apparatus as it should have.The wire was inside the actual catheter taking up much of the catheter lume.This caused a clot to form and the catheter became unusable.An x-ray was appropriately performed to make sure a piece of wire had not broken free inside the patient.No wire was seen.Bard company/reps were notified, a picture was sent to company and their company is doing their own investigation.

• Brand Name: POWER GLIDE (18G/18CM)
• Type of Device: MIDLINE
• Manufacturer (Section D): CR BARD; covington GA
• MDR Report Key: 7562463
• MDR Text Key: 110043839
• Report Number: 7562463
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: RECP1311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR