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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SLIC COMPONENT: 7 FR X 8"; ACCESSORIES, CATHETER
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ARROW INTERNATIONAL INC. ARROW SLIC COMPONENT: 7 FR X 8"; ACCESSORIES, CATHETER Back to Search Results
Catalog Number SC-14701
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The compliant is reported as: "rn noticed patients bed was soaked and with further investigation the femoral cordis line was leaking.When looking closer we noticed the single lumen infusion catheter that was connected to the cordis line had a small crack.The patient had multiple medications infusing into this line that was leaked into the bed & floor causing a puddle & the bed to be soaked.Md brought to bedside.We switched the medications which were pressors into another central line port.Which then were titrated down and not needed.Md at bedside switched out to a new single lumen catheter." no patient injury or complication reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one slic catheter component for analysis.Signs-of-use in the form of biological material was observed on the catheter hub.After failing functional testing, two cracks were discovered on the hub of the slic component.Microscopic examination confirmed the damage.It was noted that the cracks were on opposite sides of the hub and started at the thread.The catheter body from the hub to the distal end measured 7 7/8", which is within the specification limits of 7 1/4"-8" per the catheter graphic.The catheter extrusion outer diameter measured.0925", which is within the specification limits of.090"-.094" per the catheter extrusion graphic.The catheter extrusion inner diameter at the distal end measured.060", which is within the specification limits of.057"-.061" per the catheter extrusion graphic.The inner diameter of the slic hub at the proximal opening measured.169", which is within the specification limits of.168"-.170" per the hub graphic.A lab inventory syringe filled with water was attached to the slic hub and aspirated.Water was observed leaking out of the cracks on the hub.Performed per ifu statement, "hemostasis valve/side port assembly to slic connection and slic to obturator connection must be secured and routinely examined to minimize the risk of disconnection and possible air embolism , hemorrhage, or exsanguination".The ifu provided with the kit informs the user, "to use the slic for intravenous infusion, remove the blue-capped slic obturator by twisting counter clockwise.Hold the infusion port to maintain positive lock to hemostasis valve housing.Pull the slic obturator from the infusion catheter.Immediately attach desired line to luer-lock hub".The report of a cracked luer hub was confirmed through complaint investigation.Visual analysis revealed that the hub of the slic contained two cracks on either side of the hub.Despite the damage, the slic met all relevant dimensional requirements.The appearance of the failure mode appears consistent with damage due to overtightening on the hub.Therefore, the root cause for this complaint is likely user error.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The compliant is reported as: "rn noticed patients bed was soaked and with further investigation the femoral cordis line was leaking.When looking closer we noticed the single lumen infusion catheter that was connected to the cordis line had a small crack.The patient had multiple medications infusing into this line that was leaked into the bed & floor causing a puddle & the bed to be soaked.Md brought to bedside.We switched the medications which were pressors into another central line port.Which then were titrated down and not needed.Md at bedside switched out to a new single lumen catheter." no patient injury or complication reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW SLIC COMPONENT: 7 FR X 8"
Type of Device
ACCESSORIES, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11416287
MDR Text Key243137557
Report Number9680794-2021-00083
Device Sequence Number1
Product Code KGZ
Combination Product (y/n)N
PMA/PMN Number
K781846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/17/2021
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 NumberSC-14701
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Initial Date Manufacturer Received 02/17/2021
Initial Date FDA Received03/04/2021
Supplement Dates Manufacturer Received03/29/2021
Supplement Dates FDA Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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