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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN915682
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Event Description
It was reported that: a cvc was placed in the patient and after 125 days in situ a hole was discovered in the catheter.The issue was identified during flushing.The catheter was removed.There was no reported patient harm or consequence.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: a cvc was placed in the patient and after 125 days in situ a hole was discovered in the catheter.The issue was identified during flushing.The catheter was removed.There was no reported patient harm or consequence.
 
Manufacturer Narrative
(b)(4).The customer returned one, 3-lumen cvc for analysis.Signs of use in the form of biological material were observed on the catheter body.After failing functional testing, a hole was observed on the catheter body.The edges of the hole were smooth and appear consistent with damage due to contact with a sharp instrument.The location of the hole measured 60mm from the juncture hub.The catheter body length measured 323mm from the juncture hub, which is within the specification limits of 310mm-330mm per the catheter product drawing.The catheter body outer diameter measured 2.44mm, which is within the specification limits of 2.39mm-2.49mm per the catheter extrusion product drawing.A lab inventory syringe fille with water was attached to all three extension lines and flushed.When flushing the medial lumen, water leaked out of the hole on the catheter body.No leaks were observed when flushing the distal or proximal lumens.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The report of a leaking catheter was confirmed through complaint investigation.Visual analysis revealed a hole on the catheter body.During functional analysis, leaking was observed from this hole when flushing the medial extension line.The edges of the hole were smooth and appear consistent with damage due to contact with a sharp instrument.Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the damage was observed after 15 days of use and the appearance of the damage, unintentional use error (contact with sharps) 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
CVC SET: 3-LUMEN 7FR X 30CM
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18334659
MDR Text Key330676721
Report Number3006425876-2023-01241
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGM
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 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915682
Device Catalogue NumberDE-24703-UKO
Device Lot Number71F22L0199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2022
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
NOT REPORTED; NOT REPORTED
Patient SexMale
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