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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CV-42703
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Cardiac Arrest (1762); Reaction (2414)
Event Date 07/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional information received: the resuscitation was successful following the cardiac arrest.The patient did not have a history of an allergy to chlorhexidine.The patient recovered well and surgical procedure was performed at a later date.
 
Event Description
It was reported that "anaphylactic shock to chlorhexidine impregnation on the line.Severe anaphylaxis, cardiac arrest required resuscitation, itu admission.Confirmed anaphylaxis to chlorhexidine with allergy testing".
 
Manufacturer Narrative
(b)(4).The sample was not returned; however, the customer did provide two photos for evaluation.One photo was of the components inside the kit and the other photo was of the lidstock.No other defects or anomalies could be observed from the customer photos.A dhr review was performed based on the lot number from the lidstock in the customer provided photos.No manufacturing issues were identified.The ifu provided with this kit warns the user "if adverse reactions occur after catheter placement, remove catheter immediately." the report of a catheter related allergic reaction was confirmed through the customer description of the events that occurred.A dhr was performed based on the lidstock in the customer provided photo.The customer stated that a chlorohexidine coated catheter was used during this procedure and it was confirmed that the patient suffered from an allergic reaction to chlorohexidine.Therefore, unintentional user error (patient condition) caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported that "anaphylactic shock to chlorhexidine impregnation on the line.Severe anaphylaxis, cardiac arrest required resuscitation, itu admission.Confirmed anaphylaxis to chlorhexidine with allergy testing".
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9172684
MDR Text Key161721484
Report Number3006425876-2019-00755
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/19/2019
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? No
Device Operator Health Professional
Device Catalogue NumberCV-42703
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/09/2019
Supplement Dates Manufacturer Received11/04/2019
Supplement Dates FDA Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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