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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04301
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It is reported that the doctor did right internal jugular vein puncture on patient and intravenous indwelling catheter, plunger inside the syringe was loose which caused the blood can't be drawn, doctor can't identify if the puncture was successful or not.Then replaced new one to complete the puncture.The patient was anxious, and this caused pain for on patient again.
 
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.
 
Event Description
It is reported that the doctor did right internal jugular vein puncture on patient and intravenous indwelling catheter, plunger inside the syringe was loose which caused the blood can't be drawn, doctor can't identify if the puncture was successful or not.Then replaced new one to complete the puncture.The patient was anxious , and this caused pain for on patient again.
 
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Brand Name
ARROW CVC SET: 16 GA X 8" (20 CM)
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9070298
MDR Text Key159133053
Report Number3006425876-2019-00691
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Catalogue NumberES-04301
Device Lot Number71F16D0194
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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