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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL LLC MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDC-42703-P1A
Device Problem Unraveled Material (1664)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Event Description
It was reported that: "the e.D.Rn director reported that the.032 spring wire guide in the kit began to unravel, on the proximal end of the wire, during the insertion process.Entire wire was removed from the patient, without incident, & the catheter did end up being placed successfully." there was no reported patient harm or consequence.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "the e.D.Rn director reported that the.032 spring wire guide in the kit began to unravel, on the proximal end of the wire, during the insertion process.Entire wire was removed from the patient, without incident, & the catheter did end up being placed successfully." there was no reported patient harm or consequence.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and 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.
 
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Brand Name
MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM
Type of Device
CATHETER INTRAVASCULAR THERAP
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 Key19057589
MDR Text Key339559395
Report Number9680794-2024-00315
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10801902117073
UDI-Public10801902117073
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/25/2024
Device Catalogue NumberCDC-42703-P1A
Device Lot Number13F22G0110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received04/08/2024
Supplement Dates Manufacturer Received04/30/2024
Supplement Dates FDA Received05/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2022
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
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