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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SA-12853
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
It was reported the syringe-needle interface was not connecting (loose).The insertion site was the right internal jugular.A new device was used.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).
 
Manufacturer Narrative
(b)(4).The customer returned one arrow raulerson syringe (ars) and introducer needle for analysis.Signs of use were observed on the introducer needle.Visual examination of the ars and introducer needle did not reveal any defects or anomalies.The introducer needle was functionally tested with the returned ars per the instructions for use (ifu) provided with this kit which states, "insert introducer needle with attached arrow raulerson syringe (where provided) into vein and aspirate." the introducer needle was attached to the ars.The hub of the introducer needle fit snugly on the nose of the ars syringe.The returned 18 ga introducer needle felt secure on the ars and was able to draw and aspirate water.The connection between the syringe and the needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.No differences were detected.The hub of the 18 ga introducer needle was tested with the male luer gauge and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.The ifu provided with this kit states, "insert introducer needle with attached arrow raulerson syringe (where provided) into vein and aspirate." the complaint of an insecure syringe/needle connection was not able to be confirmed by a complaint investigation of the returned sample.The 18 ga introducer needle and ars met all relevant functional testing.The needle hub met iso 594-1 requirements when measured using a luer gage.Based on the product returned, no problem was found on the sample.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported the syringe-needle interface was not connecting (loose).The insertion site was the right internal jugular.A new device was used.No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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 Key12858135
MDR Text Key281873885
Report Number3006425876-2021-01088
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeSF
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 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSA-12853
Device Lot Number71F20L1914
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
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