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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04301
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The complaint is reported as: the needle did "not match" with the ars syringe during puncture on the patient.The connection between the needle hub and ars syringe was loose.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one opened kit containing an ars and introducer needle for evaluation.Visual examination of the components did not reveal any defects or anomalies.The hub of the introducer needle fit snug on the nose of the ars syringe.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the hub of the introducer needle was connected to the ars syringe.The needle was submerged in water, and aspiration was replicated.The plunger was then depressed, and water exited the bevel of the needle.No leaks were detected during aspiration or purging of the water.The connection between the syringe and the needle was compared with a lab inventory ars syringe and introducer needle.The returned ars was attached to a lab inventory introducer needle.The returned introducer needle was attached to a lab inventory ars.No major differences were detected.The nose of the ars was inserted into the female luer gage and was within the specified range.The hub of the needle was tested with the male luer gage and was within the specified range.This indicates that the luers conform to iso 594-1:1986.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the customer report of ars syringe/needle connection issues could not be confirmed by complaint investigation.No anomalies were identified.The returned syringe and introducer needle were able to aspirate and purge water with no leaks being detected.The connection between the needles and the syringe was also compared to another syringe and needles from lab inventory and no major differences were detected.Both luer connectors met iso 594-1:1986 luer taper requirements.A device history record review was performed with no relevant findings.No problem was found with the returned components.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
The complaint is reported as: the needle did "not match" with the ars syringe during puncture on the patient.The connection between the needle hub and ars syringe was loose.No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 16 GA X 8" (20 CM)
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11619657
MDR Text Key243956070
Report Number3006425876-2021-00316
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberES-04301
Device Lot Number71F20H2506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Date Manufacturer Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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