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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 8CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-00820
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 10/13/2023
Event Type  malfunction  
Event Description
It was reported "the guide wire is bent/broken.".No patient harm or injury.At the time of this report, additional information is unavailable.If further information is provided, the complaint file will be updated.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel".The ifu also states, "use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire".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 guide wire is bent/broken.".No patient harm or injury.At the time of this report, additional information is unavailable.If further information is provided, the complaint file will be updated.
 
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Brand Name
ARROW ARTERIAL CATH SET: 20 GA X 8CM
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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18681416
MDR Text Key335047051
Report Number3006425876-2024-00105
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K093050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/22/2024
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-00820
Device Lot Number71F22B0926
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/09/2024
Supplement Dates Manufacturer Received03/12/2024
Supplement Dates FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2022
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
NONE REPORTED; NONE REPORTED
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