MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Burning Sensation (2146)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported via ms&s "we have had several needle dislodgements from the porta cath site due to various reasons.The affected patients are ambulatory pump patients who go home with a 46 hour chemotherapy infusion pump.Two have recently caused a caustic burn to the skin over the port site.Are you aware of any additional securement devices available or measures implemented from other facilities that would help prevent the huber needle dislodgements? we dress each site with tegaderm only." ms&s response "informed we make multiple port access needles with variations in specifications.We have 0.75", 1", and 1.5" needles with and without wings.Port access needles that are too short can fall out of the septum and leak medications onto the skin.The guardiva dressing and biopatch dressing sometimes are used against the skin with needle access.These antimicrobial dressings can keep some of the needle out of the port making it more likely that a short needle could dislodge.I have also seen where if the needle is too long, when placed in the port septum there is excess needle not in the septum.It can be pulled by the tegaderm and the needle pulled out.Port needles that are placed in the septum at an angle other than 90 degrees have a tendency to dislodge.We do sell the sentrinex 3d dressing which may be an option for port needle securement (emailed catalog).I have seen tegaderm dressings taped down with tape strips for additional securement.Patients who have had their ports for longer can have wear and tear to the port septum.This type of damage, usually from larger needles, can cause a septum to not "hold" a port needle in place.Avoid placing the port needle in the exact same area of the septum when accessing.I would have the clinicians drill down on what needle(s) they are using to access which clearvue port(s).Depth of port placement, swelling in the area, and the use of a bio-patch or guardiva at the site will need to be considerations for the clinician accessing the port in determining the appropriate needle length".This report addresses the second of two devices.

• Brand Name: PORT ACCESS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11862463
• MDR Text Key: 252400172
• Report Number: 3006260740-2021-01908
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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