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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 05/22/2020
Event Type  Death  
Manufacturer Narrative

(b)(4). Report# mw5096534.

 
Event Description

According to the maude report: "pt was two days post cabg when he suffered a cardiac arrest after a blood transfusion. During cpr, it was noted that his triple lumen catheter had become un-attached and one of the pots was broken away from the hub - leaving the port open to air. During investigation, it was noted that the plastic "tail" broke loose from the blue plastic hub (connection). There did not appear to be a cut or tear in the actual tubing, it appeared to have separated at the point of attachment where it is glued into the hub". Patient reported to be deceased.

 
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Brand NameARROW CVC KIT: 3-LUMEN
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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
9194334854
MDR Report Key10850821
MDR Text Key216587804
Report Number9680794-2020-00456
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVASCULAR UNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
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 TREATMENT DATA
Date Received: 11/17/2020 Patient Sequence Number: 1
Treatment
NONE REPORTED.
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