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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN CVC KIT: 2L 7 FR X 16 CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW MULTILUMEN CVC KIT: 2L 7 FR X 16 CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SA-12702-J
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 02/01/2023
Event Type  malfunction  
Event Description
It was reported the catheter migrated from the internal jugular vein.The catheter migrated 5cm from the distal end of where the catheter was in the patient.The dressing had partially come off from the skin and there was some "red flare and puffiness" of the skin at the insertion site.The catheter was removed from the patient and another catheter was inserted peripherally for infusion.No injury to the patient was reported.
 
Manufacturer Narrative
Qn#(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one 2-l catheter and box clamp assembly for analysis.Signs of use in the form of biological material were observed on the catheter body.Visual analysis revealed that the box clamp was returned attached to the catheter body; however, it was located over the distal end.Visual analysis of the catheter, clamp fastener, and clamp catheter did not reveal any defects or anomalies.There is no evidence to suggest that the catheter suture wings (on juncture hub) were ever secured with sutures.The outer diameter of the returned catheter body measured to be 2.46mm, which is within specifications of 2.36mm-2.46mm per product drawing.The inner diameter of the clamp fastener measured 4.4704mm, which is within the specification limits of 4.32mm - 4.57mm pe r the clamp fastener product drawing.The catheter clamp and fastener were attached to the returned catheter body.The box clamp assembly was held stationary, and the catheter was pulled in both directions.Little to no movement was identified.The suture wings of the juncture hubs were then held stationary, and the catheter was pulled in both directions.No movement was identified.Performed per ifu statement , "secure catheter to patient.Use triangular juncture hub with integral suture ring and side wings as primary suture site.In kits where provided, the catheter clamp and fastener should be utilized as a secondary suture site as necessary".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "secure catheter to patient.Use triangular juncture hub with integral suture ring and side wings as primary suture site.In kits where provided, the catheter clamp and fastener should be utilized as a secondary suture site as necessary".The customer did not state whether the catheter juncture hub was used as the primary securement site.The customer report of a catheter migration could not be confirmed by complaint investigation of the returned sample.Little to no movement of the catheter was observed when secured by only the box clamp.The catheter also passed testing when secured by the juncture hub suture wings.The primary suture location for this catheter is the juncture hub using the triangular wings.It could not be determined if the box clamp was used as the primary or secondary suture site; therefore, the probable cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
It was reported the catheter migrated from the internal jugular vein.The catheter migrated 5cm from the distal end of where the catheter was in the patient.The dressing had partially come off from the skin and there was some "red flare and puffiness" of the skin at the insertion site.The catheter was removed from the patient and another catheter was inserted peripherally for infusion.No injury to the patient was reported.
 
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Brand Name
ARROW MULTILUMEN CVC KIT: 2L 7 FR X 16 CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
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 Key16463588
MDR Text Key310496824
Report Number3006425876-2023-00190
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date03/31/2024
Device Catalogue NumberSA-12702-J
Device Lot Number71F22D1033
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2022
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
NOT REPORTED; NOT REPORTED
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