MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) POWERPICC HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN

Catalog Number 3385335Q

Device Problems Unraveled Material (1664); Human-Device Interface Problem (2949)

Patient Problem Embolism (1829)

Event Type  Injury  

Event Description

A nurse did hand-over-hand removal on the catheter and noticed the end looked funny at the 6cm mark.They performed an ultrasound and found that the catheter had fractured.Performed surgery (b)(6) 2014.Additional information obtained picc was being removed due to completion of treatment.No difficulty with removal.Facility sated rn unfamiliar with products had previously used other products that has blue tip on the end.Rn mistakenly felt that catheter tip had broken.Pt was sent for use and chest x-ray which showed foreign body.The pt was transferred to another facility for vascular surgery.The facility is following up with vascular surgeon to determine if anything was removed.Facility reported that she received the entire picc (55 cm) and feels that the catheter did not break but attributes confusion to rn lack of experience.Vascular surgeon reported guidewire removal.Facility confirmed with insertion practitioner that guidewire was unravelled when removed.Notified facility that this event has been known to happen when guidewire is removed through introducer needle.Facility confirmed that practitioner did fray guidewire by pulling through introducer needle.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rexj0369 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN
• Manufacturer (Section D): C.R. BARD, INC. (BASD); salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city, UT 84116 ; 8015950700
• MDR Report Key: 3609091
• MDR Text Key: 4088934
• Report Number: 3006260740-2014-00030
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3385335Q
• Device Lot Number: REXJ0369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention