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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 5CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 5CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-00520-PBX
Device Problem Obstruction of Flow (2423)
Patient Problem Insufficient Information (4580)
Event Date 12/28/2022
Event Type  malfunction  
Event Description
Customer reports "sample impossible".There is "damping of the curve then early obstruction of the catheter (in less than 24 hours after its insertion)".No patient information was available.Patient condition was not reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reports "sample impossible".There is "damping of the curve then early obstruction of the catheter (in less than 24 hours after its insertion)".No patient information was available.Patient condition was not reported.
 
Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The complaint of catheter blocked was not able to be confirmed by the photo which only shows the lidstock.A complete visual inspection could not be performed as no sample was returned for analysis.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 use if package is damaged." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW ARTERIAL CATH SET: 20 GA X 5CM
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 Key16239806
MDR Text Key308193094
Report Number3006425876-2023-00046
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
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 12/28/2022
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 NumberSAC-00520-PBX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/28/2022
Initial Date FDA Received01/25/2023
Supplement Dates Manufacturer Received02/06/2023
Supplement Dates FDA Received02/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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