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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 3-L CVC KIT: 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW 3-L CVC KIT: 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-45703-1A
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient was being repositioned when the line was pulled causing the proximal hub to become detached from the line. No patient harm was reported. The patient's condition is reported as fine.
 
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Brand NameARROW 3-L CVC KIT: 7 FR X 20 CM
Type of DeviceCATHETER 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 Key15009074
MDR Text Key302431025
Report Number9680794-2022-00421
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-45703-1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/04/2022
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: 07/13/2022 Patient Sequence Number: 1
Treatment
NOT REPORTED.; NOT REPORTED.
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