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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported: cracked hub of slic catheter causing blood leakage.It was reported there was no patient injury or harm.The patient did not have significant blood loss.The patient's pillow was found to be wet with blood and iv fluid leaking from a crack in the right internal jugular slic hub.Infusions were moved to the side arm of the introducer and the slic was removed and obturator inserted into the introducer.The patient had repeat bloodwork drawn and a chest x-ray done.The patient's condition is "stable".A picc was ordered for the next morning as well as slic prn.
 
Event Description
Customer reported: cracked hub of slic catheter causing blood leakage.It was reported there was no patient injury or harm.The patient did not have significant blood loss.The patient's pillow was found to be wet with blood and iv fluid leaking from a crack in the right internal jugular slic hub.Infusions were moved to the side arm of the introducer and the slic was removed and obturator inserted into the introducer.The patient had repeat bloodwork drawn and a chest x-ray done.The patient's condition is "stable".A picc was ordered for the next morning as well as slic prn.
 
Manufacturer Narrative
(b)(4).The customer provided one image for analysis.Visual analysis revealed that the catheter hub was cracked.Signs of use were also observed.The customer returned one slic catheter connected to a non-arrow connector assembly.Signs of use in the form of biological material were observed.Visual analysis revealed that the hub of the slic catheter was severely cracked.Moderate force was required to remove the connector assembly from the slic hub.Once removed, microscopic examination confirmed the damage.The non-arrow connector assembly was removed from the slic catheter with moderate force.Once removed , a lab inventory syringe filled with water was attached to the slic catheter hub and flushed.Water was immediately observed leaking from the crack in the hub.Performed per ifu statement , "maintain catheter patency according to institutional policies, procedures and practice guidelines".R & d was contacted as part of this complaint investigation.The hub of slic catheters is molded separately before it is assembled to the catheter body.They also indicated that unintentional use error likely caused or contibuted to this event.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of a damaged luer hub was confirmed through complaint investigation.Visual analysis revealed a large crack on the hub of the slic catheter.This resulted in leaking when flushing with a lab inventory syringe.A device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from r & d, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
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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 Key16552317
MDR Text Key311525499
Report Number9680794-2023-00166
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,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberSS-14701
Device Lot Number14F22F0287
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2022
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
LEVOPHED; LEVOPHED
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