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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA
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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA Back to Search Results
Catalog Number CS-15242-VSP
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The complaint is reported as: after the catheter is positioned, "the tunnel needle cannot be tightly connected to the catheter connection end (red buckle)".The user had to use "surgical forceps to pass through the tunnel under the skin, and then clamp the tip of the catheter, pulled out the catheter from the tunnel with force" which leads to "serious tunnel tear and crack" under the skin of the patients and "prolongs the operation time".No patient injury or complication reported.It was reported the patient is "in good condition and not harmed".
 
Manufacturer Narrative
Qn# (b)(4).The customer supplied a video showing the reported defect of the tunneling instrument and catheter disconnection issue.The video shows that the catheter and tunneler are easily disconnected.The customer also returned a tunneling instrument and the proximal end of the catheter body for analysis.Potential signs-of-use in the form of biological material was observed inside the catheter body.Visual analysis did not reveal any defects or anomalies of any kind.Per measurement d in the tunneling graphic, the outer diameter of the tunneling instrument at the distal tip measured.0737", which is not within the specification limits of.076"-.078".This same measurement was taken with the starrett machine in the r & d lab.The outer diameter measured.06888", which further confirms that the outer diameter is not within specification limits.The inner diameter of the catheter body at the proximal tip measured.081" , which is within the specification limits of.081"-.083" per the catheter connector graphic.The returned tunneling instrument was inserted into the proximal end of the catheter body.It was observed that the connection was not secure as the tunneling instrument easily became dislodged.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with this kit provides the following warnings, cautions and instructions for the user: "do not tunnel through muscle." "do not forcefully pull tunneler and catheter apart; catheter breakage may occur." "do not pull tunneler out of the venous insertion site on an angle; pull parallel to the body." "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract.Remove catheter clamp." "slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark." the reported complaint of tunneler / catheter disconnecting was confirmed through examination of the returned sample as well as the customer supplied video.Visual analysis did not reveal any defects or anomalies of any kind; however, functional and dimensional testing confirmed that the tunneler outer diameter near the distal tip was not within the specification limits of the product drawing.A device history record review was performed with no evidence to suggest a manufacturing related cause.Based on the report from the customer and the sample received, the root cause for this issue is likely supplier related.A nonconformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The complaint is reported as: after the catheter is positioned, "the tunnel needle cannot be tightly connected to the catheter connection end (red buckle)".The user had to use "surgical forceps to pass through the tunnel under the skin, and then clamp the tip of the catheter, pulled out the catheter from the tunnel with force" which leads to "serious tunnel tear and crack" under the skin of the patients and "prolongs the operation time".No patient injury or complication reported.It was reported the patient is "in good condition and not harmed.".
 
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Brand Name
ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
Type of Device
CATHETER, HEMODIALYSIS, IMPLA
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11292489
MDR Text Key230711517
Report Number9680794-2021-00039
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
PMA/PMN Number
K111117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/31/2023
Device Catalogue NumberCS-15242-VSP
Device Lot Number13F20F0025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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