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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 Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 01/09/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "the arterial catheter was inserted on (b)(6) 2024.The day after the catheter was not inserted anymore." the device was discarded and another catheter was inserted.The patient's status is "unknown".At the time of this report, the customer has not returned our request for additional information.If further information is received, the complaint file will be updated.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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.
 
Event Description
It was reported "the arterial catheter was inserted on (b)(6) 2024.The day after the catheter was not inserted anymore." the device was discarded and another catheter was inserted.The patient's status is "unknown".At the time of this report, the customer has not returned our request for additional information.If further information is received, the complaint file will be updated.
 
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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 Key18627300
MDR Text Key334355829
Report Number3006425876-2024-00089
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K093050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSAC-00520-PBX
Device Lot Number71F23G0263
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2023
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
Patient Age22 YR
Patient Weight70 KG
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