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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 0600650CE
Device Problem Occlusion Within Device (1423)
Patient Problem No Code Available (3191)
Event Date 03/08/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.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 that while aspirating the catheter a ¿clot¿ was coming out of the lumen.The healthcare professional continued aspirating, as per hospital procedures, until they had blood return.The device was placed (b)(6) 2017, for receiving bone marrow transplant.It was stated that the facility has switched to a heparin free hospital for catheters since last year.They have seen ¿clots¿ in other catheters, but they do not have any information for these incidents.
 
Manufacturer Narrative
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 occluded catheter is inconclusive, poor sample condition.The sample returned was one photograph.The photograph appears to show two sections of blood product accumulation placed on top of a gauze pad.No device is shown.As the photo shows what appears to be clotted blood, but it is not clear where the clotting has taken place or what caused it, the complaint is inconclusive due to poor sample condition.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 that while aspirating the catheter a ¿clot¿ was coming out of the lumen.The healthcare professional continued aspirating, as per hospital procedures, until they had blood return.The device was placed (b)(6) 2017, for receiving bone marrow transplant.It was stated that the facility has switched to a heparin free hospital for catheters since last year.They have seen ¿clots¿ in other catheters, but they do not have any information for these incidents.
 
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Brand Name
HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT
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
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key7394482
MDR Text Key104427426
Report Number3006260740-2018-00574
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K830233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0600650CE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 03/13/2018
Initial Date FDA Received04/03/2018
Supplement Dates Manufacturer Received03/13/2018
Supplement Dates FDA Received06/22/2018
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
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