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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5-LUMEN 9.5FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL LLC ARROW CVC SET: 5-LUMEN 9.5FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN916851
Device Problems Crack (1135); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2023
Event Type  malfunction  
Event Description
It was reported that: when attempting to insert a cvc in the right subclavian vein of the patient, the first puncture hit the bone, the second and third attempt aspirated air.Inspection of the puncture needle revealed several "tears" in the plastic cone of the needle.Additional information: there were no issues prepping or flushing the introducer needle prior to the procedure.Disinfectant wipe was used to clean the needle.Ultrasound was not used.There was no exceptional force used.It was the same needle used for the 3 attempts.No air, particulate or component entered the vasculature.There was no reported patient harm or consequence from the incident.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: when attempting to insert a cvc in the right subclavian vein of the patient, the first puncture hit the bone, the second and third attempt aspirated air.Inspection of the puncture needle revealed several "tears" in the plastic cone of the needle.Additional information: there were no issues prepping or flushing the introducer needle prior to the procedure.Disinfectant wipe was used to clean the needle.Ultrasound was not used.There was no exceptional force used.It was the same needle used for the 3 attempts.No air, particulate or component entered the vasculature.There was no reported patient harm or consequence from the incident.
 
Manufacturer Narrative
(b)(4).The customer report of a cracked needle hub was confirmed through complaint verification of the returned sample.The customer returned one 18ga introducer needle for analysis.No definite signs of use were observed on the needle and no other components from the kit were returned.Visual analysis of the introducer needle revealed several lateral cracks in the hub.Microscopic examination confirmed the cracks and revealed they were emanating from the proximal luer opening.The needle was attached to a lab inventory 10ml syringe and functionally tested per the instructions for use (ifu) provided with this kit, which states "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the syringe was not able to draw and aspirate water with the returned introducer needle.Water was observed to leak out of the crack in the needle hub.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Capa has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.The capa investigation indicates the root cause was design related.Teleflex has identified that the needle hub material was susceptible to cracking when placed under stress (i.E., pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.Corrective actions have not yet been fully implemented.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC SET: 5-LUMEN 9.5FR 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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17296963
MDR Text Key318745373
Report Number3006425876-2023-00663
Device Sequence Number1
Product Code FOZ
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 Physician
Type of Report Initial,Followup
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN916851
Device Catalogue NumberDE-14955-CV
Device Lot Number71F22E1077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/15/2023
Initial Date FDA Received07/11/2023
Supplement Dates Manufacturer Received07/26/2023
Supplement Dates FDA Received07/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2022
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
NOT REPORTED; NOT REPORTED
Patient Age50 YR
Patient SexMale
Patient Weight85 KG
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