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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25703-E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The complaint is reported as: "the junction site between extension line and luer-hub (brown head) had a breach caused leaking." no patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.
 
Event Description
The complaint is reported as: "the junction site between extension line and luer-hub (brown head) had a breach caused leaking." no patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(6).The customer returned one 3-l catheter for evaluation.Visual inspection of the catheter revealed there was a large hole in the distal extension line adjacent to the luer hub.The total length of the catheter measured 220 mm which is within specifications of 207-227 mm per catheter graphic drawing.The outer diameter of the distal extension line measured 2.179 mm which is within specifications of 2.130-2.210 mm per distal extrusion graphic.The inner diameter of the distal extension line measured 1.4732 mm which is within specifications of 1.42-1.50 mm per distal extrusion graphic.This indicates that the wall thickness measured within specifications.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "flush lumen(s) to completely clear blood from catheter." when the distal line was flushed, water leaked from the hole adjacent to the luer hub.No leaks were observed when the proximal and medial lumens were flushed.A manual tug test confirmed that all three extension lines were secure within their respective luer hubs.The customer did not provide a lot number.Therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.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 customer report of an extension line leak was confirmed by functional and visual inspection of the returned sample.The distal extension line contained a hole adjacent to the luer.A device history record review was performed based on sales history, and no relevant findings were identified.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The root cause of this issue has not yet been determined.Teleflex will continue to monitor and trend reports of this nature.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
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 Key12610059
MDR Text Key276605914
Report Number3006425876-2021-00955
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/23/2021
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 Catalogue NumberCS-25703-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/23/2021
Initial Date FDA Received10/11/2021
Supplement Dates Manufacturer Received11/12/2021
Supplement Dates FDA Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
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
NONE REPORTED.; NONE REPORTED.
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