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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER
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ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER Back to Search Results
Catalog Number PR-05042
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
When puncturing the vein, the guidewire is advanced without complication, and the introducer is advanced together with the dilator.When the introducer is withdrawn, the catheter is advanced but without success.The device is not used.No patient harm reported.The patient's condition is reported as fine.
 
Event Description
When puncturing the vein, the guidewire is advanced without complication, and the introducer is advanced together with the dilator.When the introducer is withdrawn, the catheter is advanced but without success.The device is not used.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
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Brand Name
ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM)
Type of Device
CATHETER, INTRAVASCULAR, THER
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 Key16183943
MDR Text Key308149609
Report Number9680794-2023-00050
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K042126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberPR-05042
Device Lot Number14F22F0126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2022
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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