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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET: 20 GA X 5CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARTERIAL CATH SET: 20 GA X 5CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number SAC-00520-PBX
Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that " we found the product with damaged packaging inside the box during receipt and labeling inspection.".Investigation of the returned sample showed that the swg was kinked.This is a reportable malfunction.
 
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Brand Name
ARTERIAL CATH SET: 20 GA X 5CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18561299
MDR Text Key333437943
Report Number3006425876-2024-00086
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K093050
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 01/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberSAC-00520-PBX
Device Lot Number71F22J2856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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