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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SLIC COMPONENT: 7 FR X 6IN; ACCESSORIES, CATHETER
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ARROW INTERNATIONAL LLC ARROW SLIC COMPONENT: 7 FR X 6IN; ACCESSORIES, CATHETER Back to Search Results
Catalog Number SS-14701
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 12/08/2022
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported "slic cracked near hub causing blood and medications to leak from catheter." it was reported the patient was running sedation for respiratory issues and vasopressors as he was hemodyanamically unstable.No medical intervention was necessary.At the time of this report, the patient was in icu unrelated to this event.
 
Manufacturer Narrative
(b)(4) the customer returned one slic component for analysis.Signs of use were observed on the returned component.Visual analysis revealed that the luer hub was damaged and cracked.Microscopic examination confirmed that the luer hub had lateral cracks down the body.The appearance of the damage is consistent with overtightening of the luer hub.The overall length of the slic component is 6 1/8", which is within the specification limits of 5 7/8" - 6 1/8" per the slic product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which states "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture." the catheter was flushed with a lab inventory syringe, and a leak was observed at the level of the luer hub.The ifu provided with this kit informs the user, "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 customer report of a damaged luer hub was confirmed by complaint investigation of the returned sample.Visual and microscopic analysis revealed that the luer hub contained a crack.The appearance of the crack was consistent with over-tightening on the luer hub.Additionally, the component passed all relevant dimensional analysis.Based on the customer report and the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
Customer reported "slic cracked near hub causing blood and medications to leak from catheter." it was reported the patient was running sedation for respiratory issues and vasopressors as he was hemodyanamically unstable.No medical intervention was necessary.At the time of this report, the patient was in icu unrelated to this event.
 
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Brand Name
ARROW SLIC COMPONENT: 7 FR X 6IN
Type of Device
ACCESSORIES, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key16160837
MDR Text Key308562162
Report Number9680794-2023-00043
Device Sequence Number1
Product Code KGZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K781846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberSS-14701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received02/06/2023
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
Treatment
SEDATION AND VASOPRESSORS; SEDATION AND VASOPRESSORS
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