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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER SUBCLAVIAN
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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER SUBCLAVIAN Back to Search Results
Catalog Number CS-15122-F
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the ars syringe was found leaking during puncture on the patient.No patient harm reported.The patient's condition is reported as fine.
 
Event Description
It was reported the ars syringe was found leaking during puncture on the patient.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one opened hemodialysis set containing an arrow raulerson syringe (ars), catheter, 18 ga introducer needle, ca theter/needle assembly, and spring wire guide for evaluation.Significant signs of use were present on all the returned components.Visual examination of the components revealed the introducer needle cannula was slightly bent and the swg was kinked.Visual inspection of the ars and other components did not reveal any anomalies or defects.After the ars failed the vacuum test (see below), the handle was broken to examine the valves inside.The valve mechanism consists of two bi-lateral valves and a spacer.The proximal valve was noted to have a hole in the slit.The distal valve was intact.The syringe was able to successfully draw and aspirate water with and without the returned introducer needle attached (per amrq-000113 rev 3 req 6.1).The module requirement document for raulerson syringes (amrq-000113 rev 3) was reviewed to determine requirements for air/water leakage.The document notes a deviation from iso 7886-1: "the freedom of air and liquid leakage past the piston requirement is design restrictive and is intended for an injection-intended syringe, not the ars.The opening in the center of the piston that allows passage of the inner cannula prohibits the ars from meeting the pressure and vacuum requirements as dictated by the standard.However, because the intended use of the ars is to allow aspiration of blood to ensure venous placement of the introducer needle and to aid in the insertion of the spring wire guide, the leakage requirements of a standard syringe are not applicable to the ars." a vacuum test was performed on the ars syringe in order to verify that the internal valves within the plunger body were intact.With the plunger body at the bottom of the syringe, the tip of the ars was occluded, and the plunger was pulled back until it stopped.With the tip of the ars still occluded, the plunger was released but did not snapped back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are not functioning as intended.A device history record review was performed, and no relevant findings were found.The issue of the ars leaking was confirmed during functional testing of the returned sample.The returned syringe failed the vacuum test.Further examination of the valves revealed a small puncture hole in the proximal valve.A device history record review did not reveal any relevant findings.A capa has been initiated to further investigate this complaint issue.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend reports of this nature.Corrected data: investigation findings and investigation conclusion codes added to section h.6.
 
Event Description
It was reported the ars syringe was found leaking during puncture on the patient.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one opened hemodialysis set containing an arrow raulerson syringe (ars), catheter, 18 ga introducer needle, ca theter/needle assembly, and spring wire guide for evaluation.Significant signs of use were present on all the returned components.Visual examination of the components revealed the introducer needle cannula was slightly bent and the swg was kinked.Visual inspection of the ars and other components did not reveal any anomalies or defects.After the ars failed the vacuum test (see below), the handle was broken to examine the valves inside.The valve mechanism consists of two bi-lateral valves and a spacer.The proximal valve was noted to have a hole in the slit.The distal valve was intact.The syringe was able to successfully draw and aspirate water with and without the returned introducer needle attached (per amrq-000113 rev 3 req 6.1).The module requirement document for raulerson syringes (amrq-000113 rev 3) was reviewed to determine requirements for air/water leakage.The document notes a deviation from iso 7886-1: "the freedom of air and liquid leakage past the piston requirement is design restrictive and is intended for an injection-intended syringe, not the ars.The opening in the center of the piston that allows passage of the inner cannula prohibits the ars from meeting the pressure and vacuum requirements as dictated by the standard.However, because the intended use of the ars is to allow aspiration of blood to ensure venous placement of the introducer needle and to aid in the insertion of the spring wire guide, the leakage requirements of a standard syringe are not applicable to the ars." a vacuum test was performed on the ars syringe in order to verify that the internal valves within the plunger body were intact.With the plunger body at the bottom of the syringe, the tip of the ars was occluded, and the plunger was pulled back until it stopped.With the tip of the ars still occluded, the plunger was released but did not snapped back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are not functioning as intended.A device history record review was performed, and no relevant findings were found.The issue of the ars leaking was confirmed during functional testing of the returned sample.The returned syringe failed the vacuum test.Further examination of the valves revealed a small puncture hole in the proximal valve.A device history record review did not reveal any relevant findings.A capa has been initiated to further investigate this complaint issue.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend reports of this nature.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Type of Device
CATHETER SUBCLAVIAN
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12639506
MDR Text Key276642927
Report Number3006425876-2021-00962
Device Sequence Number1
Product Code LFJ
Combination Product (y/n)N
PMA/PMN Number
K895417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCS-15122-F
Device Lot Number71F20J0292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Date Manufacturer Received11/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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