• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (BASD) -3006260740 PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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 first of two devices.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePORT ACCESS NEEDLE
Type of DeviceSET, 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 Key11862459
MDR Text Key252399616
Report Number3006260740-2021-01907
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
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 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
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 Treatment Data
Date Received: 05/21/2021 Patient Sequence Number: 1
-
-