Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
  • 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
 

BARD ACCESS SYSTEMS HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 0600600
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2016
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.Device not returned, at this time.
 
Event Description
Per sales representative, facility reported that during placement, the tissue in growth cuff slid down the catheter shaft when pulling the tunneler.Catheter was removed ok and a new one was placed.No patient injury reported.(b)(6) 2016 per report from facility, the catheter with the loose growth cuff was never placed in patient.
 
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a dislodged surecuff was confirmed, however the exact cause could not be determined.The implicated and returned product was a 9 fr d/l hickman catheter.At 20 centimeters distal to the bifurcation site, adhesive residue was observed, which appears to be the remnant of the surecuff.Tactile examination showed the region near the site of the surecuff, and the 5 cm proximal to the cuff site showed increased tensile weakness.Microscopic examination showed adhesive residue on the catheter.No functional deficiencies were found in the catheter aside from the missing surecuff.The tensile weakness indicates the catheter had likely been forcefully pulled from the proximal end, while the rest of the catheter was lodged in the body.The surecuff is supposed to be secured in a way that would be difficult to dislodge it under normal use.It could not be determined whether there were manufacturing errors that contributed to the observed failure, or if the failure was use-related.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS
Type of Device
PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key5465272
MDR Text Key39484043
Report Number3006260740-2016-00061
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741051890
UDI-Public(01)00801741051890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K830233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2020
Device Catalogue Number0600600
Device Lot NumberHUZK0342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2016
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received04/11/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
Patient Weight68
-
-