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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/12/2022
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).The report number is (b)(4).
 
Event Description
Complaint found in maude database reports: "a 20ga endurance catheter inserted on (b)(6) 2022.When the catheter was discontinued on (b)(6) 2022 approx 5cm of the catheter tip was retained.Surgical intervention was required to retrieve the retained catheter.".
 
Manufacturer Narrative
Qn#(b)(4).The mdr report key is 14188122.The mdr text key is 289978535.The report number is mw5109276.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.Corrected data: section e.4.Corrected to 'yes'.
 
Event Description
Complaint found in maude database reports: "a 20ga endurance catheter inserted on (b)(6) 2022.When the catheter was discontinued on (b)(6) 2022 approx 5cm of the catheter tip was retained.Surgical intervention was required to retrieve the retained catheter.".
 
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Brand Name
ARROW EXT DWELL CATH DEVICE
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 Key14578000
MDR Text Key293266510
Report Number9680794-2022-00357
Device Sequence Number1
Product Code FOZ
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 Other
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVASCULAR UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/01/2022
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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