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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 18GA X 12CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 18GA X 12CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-01218
Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The customer reports that it was impossible to use the swg (spring wire guide) because it was kinked in the packaging.
 
Manufacturer Narrative
Qn#(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.
 
Event Description
The customer reports that it was impossible to use the swg (spring wire guide) because it was kinked in the packaging.
 
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Brand Name
ARROW ARTERIAL CATH SET: 18GA X 12CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9506921
MDR Text Key179442172
Report Number3006425876-2019-01089
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K093050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberSAC-01218
Device Lot Number71F19G0781
Was Device Available for Evaluation? No
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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