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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 1L: 4.5FR X 15CM; MIDLINE CATHETER
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ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 1L: 4.5FR X 15CM; MIDLINE CATHETER Back to Search Results
Catalog Number CDC-41541-MPK1A
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: the tab from the peal away sheath broke away, during use on patient.The entire sheath was removed, and a new sheath was used to finish the procedure.There was no reported patient harm or consequence.
 
Event Description
It was reported that: the tab from the peal away sheath broke away, during use on patient.The entire sheath was removed, and a new sheath was used to finish the procedure.There was no reported patient harm or consequence.
 
Manufacturer Narrative
(b)(4).The customer report of peel-away sheath tears incorrectly was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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
ARROW AM/AT PI MIDLINE 1L: 4.5FR X 15CM
Type of Device
MIDLINE CATHETER
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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17404445
MDR Text Key319849349
Report Number9680794-2023-00549
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161313
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 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCDC-41541-MPK1A
Device Lot Number33F23C0299
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2023
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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