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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC/PSI KIT: 3L 7FR X 16CM/8.5FR X 10CM; CATHETER,INTRAVASCULAR,THERAPE
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ARROW INTERNATIONAL LLC ARROW CVC/PSI KIT: 3L 7FR X 16CM/8.5FR X 10CM; CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number ASK-42703-PSI1
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 07/11/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "possible allergenic shock or anaphylactoid reaction, around the 5 min.Post-insertion of the cvc, pa drop to 33mmhg.Immediate shock treatment was begun.The cvc was removed as soon as possible during the surgery and changed with non-protected cvc." additional information was requested but was not available at the time of this report.
 
Event Description
The complaint is reported as: "possible allergenic shock or anaphylactoid reaction, around the 5 min.Post-insertion of the cvc, pa drop to 33mmhg.Immediate shock treatment was begun.The cvc was removed as soon as possible during the surgery and changed with non-protected cvc.".
 
Manufacturer Narrative
(b)(4).Additional information was received from the customer explaining that "pa" (from original statement "pa drop to 35mmhg") is referring to arterial pressure.The customer has also reported that "the lab testing came back as possible chlorexidine reactions".It was also reported that no cpr was required, adrenaline and steroids were administered, and the patient experienced hypotension.The patient is "fine and already back home".The device was not returned for investigation.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 report of a catheter related allergic reaction was confirmed based on the customer report.The customer report confirmed that the patient had an allergy to chlorhexidine.The labeling provided with the coated catheter states "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." therefore, based on the reported event and customer confirmation of the patient having an allergy, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC/PSI KIT: 3L 7FR X 16CM/8.5FR X 10CM
Type of Device
CATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17323495
MDR Text Key319181696
Report Number9680794-2023-00552
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K071538
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 07/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberASK-42703-PSI1
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/12/2023
Initial Date FDA Received07/14/2023
Supplement Dates Manufacturer Received08/31/2023
Supplement Dates FDA Received09/05/2023
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
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age35 YR
Patient SexMale
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