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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CV-12854
Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)
Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)
Event Date 03/14/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.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 "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.
 
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Brand Name
ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
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 Key19058954
MDR Text Key339793082
Report Number3006425876-2024-00338
Device Sequence Number1
Product Code DQY
UDI-Device Identifier10801902029239
UDI-Public10801902029239
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCV-12854
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/02/2024
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
Patient Outcome(s) Congenital Anomaly;
Patient SexMale
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