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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 Loose or Intermittent Connection (1371); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported that the needle was found separated from the syringe during removal from the patient, and the connection between the needle and the syringe was not secure and loose during insertion.A new set was used to complete the procedure.
 
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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported that the needle was found separated from the syringe during removal from the patient, and the connection between the needle and the syringe was not secure and loose during insertion.A new set was used to complete the procedure.
 
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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 Key9659483
MDR Text Key180320113
Report Number3006425876-2020-00116
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 01/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/31/2021
Device Catalogue NumberES-04301
Device Lot Number71F16D0506
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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