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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 20 CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 20 CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number ASK-04301-KR
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: 4 days after placement of the catheter, a pinhole was found about 16cm from the tip, where the catheter was ruptured.Therefore, the catheter was removed and replaced with a new one.No harm to the patient was reported.
 
Event Description
It was reported that: 4 days after placement of the catheter, a pinhole was found about 16cm from the tip, where the catheter was ruptured.Therefore, the catheter was removed and replaced with a new one.No harm to the patient was reported.
 
Manufacturer Narrative
(b)(4).The customer returned one, single-lumen cvc for analysis.Signs of use in the form of adhesive residue on the extension line was observed.After performing functional testing (see below), a hole was observed in the catheter body.Microscopic examination confirmed the hole and revealed that the edges of the damage were straight and uniform, which indicates contact with sharps caused or contributed to this event.The hole in the catheter body measured 5mm from the juncture hub.The catheter body length measured 208mm which is within the specification limits of 201.5mm-210.5mm per the catheter graphic.The catheter body outer diameter measured 1.66mm which is within the specification limits of 1.65mm-1.75mm per the catheter extrusion graphic.A lab inventory syringe filled with water was attached to the distal extension line and flushed.Water was observed leaking out of a hole in the catheter body.Performed per ifu statement "flush each lumen with sterile saline solution, to establish patency and prime lumen".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not cut guidewire to alter length".The ifu also states, "position cutting edge of scalpel away from guidewire".The report of a hole in the catheter body was confirmed through complaint investigation.Visual and functional analysis revealed a hole in the catheter body directly adjacent to the juncture hub.The appearance of the hole is consistent with damage resulting from contact with a sharp instrument (i.E.Scalpel, scissors, etc.).Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC KIT: 16 GA X 20 CM
Type of Device
CATHETER, PERCUTANEOUS
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 Key13062082
MDR Text Key282781695
Report Number3006425876-2021-01163
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date03/22/2023
Device Catalogue NumberASK-04301-KR
Device Lot Number71F21C2940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
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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