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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-PBX
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)
Patient Problem Swelling/ Edema (4577)
Event Date 07/14/2023
Event Type  malfunction  
Event Description
It was reported the patient was admitted for post laparotomy for gun shot wound.Patient had swelling on the right heel, on the same foot that had the arterial line.It was reported the catheter issue was the inability to trace blood pressure and draw blood sample.The catheter was removed and swelling subsided.It was reported the patient was discharged from icu.
 
Manufacturer Narrative
Qn# (b)(4).
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 patient was admitted for post laparotomy for gun shot wound.Patient had swelling on the right heel, on the same foot that had the arterial line.It was reported the catheter issue was the inability to trace blood pressure and draw blood sample.The catheter was removed and swelling subsided.It was reported the patient was discharged from icu.
 
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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
mariah mackinnon
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18007327
MDR Text Key326535153
Report Number3006425876-2023-01013
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K093050
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 10/04/2023
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-PBX
Device Lot Number71F22E7677
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/04/2023
Initial Date FDA Received10/25/2023
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received11/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2022
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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