Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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 PERCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-15703
Device Problem Material Separation (1562)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The patient was found with one part of the cvc separated.There was a back flow of blood.The doctor came and staff clamped the involved line with a kocher forceps.The cvc was removed.The patient's condition was reported as fine.The only clinical consequence was blood loss at the time of the incident.
 
Event Description
The patient was found with one part of the cvc separated.There was a back flow of blood.The doctor came and staff clamped the involved line with a kocher forceps.The cvc was removed.The patient's condition was reported as fine.The only clinical consequence was blood loss at the time of the incident.
 
Manufacturer Narrative
(b)(4).The customer returned one three-lumen cvc and two non-arrow luer connector extension line tubing for investigation.Visual inspection revealed the distal extension line was separated directly adjacent to the luer hub.Remains of the extension line were found inside the luer hub.Signs of use in the form of biological material were observed in the distal extension line.The total length of the catheter body measured 219 mm which is within specifications of 207mm - 227 mm per catheter product drawing.The outer diameter of the distal lumen measured to be 2.19mm which is within specifications of 2.13mm - 2.21mm per product drawing.The inner diameter of the distal lumen measured to be 1.45mm which is within specifications of 1.42mm - 1.50mm per product drawing.This indicates that the wall thickness measured within specifications.The ifu provided with this kit states the following: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the proximal and medial lumens were each flushed with a lab inventory syringe.Biological material exited both lumens.Both lumens were flushed again and this time, they flushed as expected.Functional inspection could not be performed on the distal extension line since the luer hub was separated.A manual tug test confi rmed the proximal and medial luer hubs were secured to their respective extension lines.A manual tug test could not be performed on the distal extension line since the luer hub was separated.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.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the distal extension line had separated adjacent to the luer hub.It was noted that remains of the extension line were found within the luer hub.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 complaints of this nature.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12555652
MDR Text Key274274809
Report Number3006425876-2021-00886
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,foreig
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCV-15703
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2021
Date Manufacturer Received10/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
Patient Age71 YR
Patient Weight69
-
-