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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 24 GA X 2.5CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 24 GA X 2.5CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number SAC-00324-PBX
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Physician reported catheter leaking at where the catheter meets the luer hub.The luer itself was tight.Presented as significant bleeding from the line.Was able to be controlled with slide lock.Physician reported it was in the foot of a very active toddler and the patient bled a modest amount but not so much to consider it significant harm.The patient's condition was reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).The customer provided one photo and one video showing the arterial catheter.Visual analysis revealed a leak on the extension line directly adjacent to the luer hub.The customer returned one arterial catheter for analysis.Signs-of-use in the form of biological material was observed on the catheter extension line.Visual analysis revealed that the catheter extension line leaked at the connection point between the extension line and the luer hub.It was also observed that the catheter body was kinked/bent in several locations; however, as the customer makes no reference to this is it being assumed that this occurred during shipping to the investigation site.The catheter body from the juncture hub to the distal tip measured 28mm, which is within the specification limits of 25mm-29mm per the catheter graphic.The extension line outer diameter measured 2.489mm, which is within the specification limits of 2.390mm-2.490mm per the extension line extrusion graphic.The extension line inner diameter measured 1.118mm, which is within the specification limits of 1.090mm-1.190mm per the extension line extrusion graphic.A lab inventory ars syringe filled with water was attached to the arterial catheter.The plunger was compressed, and water was observed leaking out of the hole on the distal extension line.Performed per ifu statement, "maintain catheter patency according to institutional policies, procedures and practice guidelines.All personnel who care for patients with peripheral intravascular devices must be knowledgeable about effective management to prolong catheter's dwell time and prevent injury".A manual tug test confirmed that the distal luer hub was secure to the extension line.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters".The report of a leaking catheter was confirmed through complaint investigation.Visual analysis revealed a hole in the extension line directly adjacent to the luer hub.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The root cause cannot be determined as this is not a manufacturing issue.A non-conformance request has been initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Physician reported catheter leaking at where the catheter meets the luer hub.The luer itself was tight.Presented as significant bleeding from the line.Was able to be controlled with slide lock.Physician reported it was in the foot of a very active toddler and the patient bled a modest amount but not so much to consider it significant harm.The patient's condition was reported as fine.
 
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Brand Name
ARROW ARTERIAL CATH. SET: 24 GA X 2.5CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11859890
MDR Text Key252964475
Report Number3006425876-2021-00447
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K171146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSAC-00324-PBX
Device Lot Number71F21A0688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2021
Date Manufacturer Received06/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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