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 S/L CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
  • 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 S/L CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number UNK HICKMAN S/L CATHETERS
Device Problem Failure to Infuse (2340)
Patient Problems Dyspnea (1816); Occlusion (1984); Pallor (2468)
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported in an article in the journal of heart and lung transplantation tilted " indwelling central venous catheter occlusion during chronic epoprostenol infusion " that seven episodes of chronic catheter occlusion were identified in four patients from the high-dose group through pump alerts.A guidewire was used to unblock the catheters.The status of the patients was not provided.
 
Event Description
It was reported in an article in the journal of heart and lung transplantation tilted " indwelling central venous catheter occlusion during chronic epoprostenol infusion " that seven episodes of chronic catheter occlusion were identified in four patients from the high-dose group through pump alerts.A guidewire was used to unblock the catheters.The status of the patients was not provided.
 
Manufacturer Narrative
H10: manufacturer review: a lot history record could not be completed as the lot number was not provided.Investigation summary: the device has not been returned for evaluation, therefore, the investigation is inconclusive for failure to catheter occlusion as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: journal article citation: kopec, g., waligóra, m., stepniewski, j., & podolec, p.(2018).Indwelling central venous catheter occlusion during chronic epoprostenol infusion.The journal of heart and lung transplantation, 37(7), 938¿940.Doi: 10.1016/j.Healun.2018.03.018 h10: g4, journal article citation, and article attachment.H11:section a through f - the information provided by bd 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 bd.- attachment: [2018 - kopec, g.Pdf].
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HICKMAN S/L CATHETERS
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9078396
MDR Text Key158872122
Report Number3006260740-2019-02722
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HICKMAN S/L CATHETERS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-