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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CV-47702-E
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "the spring wire guide was twisted during the insertion of the catheter so that the passage of the catheter was not possible.It was necessary to use another catheter." no patient injury or consequence reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 complaint is reported as: "the spring wire guide was twisted during the insertion of the catheter so that the passage of the catheter was not possible.It was necessary to use another catheter." no patient injury or consequence reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11214375
MDR Text Key228443516
Report Number3006425876-2021-00034
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/12/2021
Device Catalogue NumberCV-47702-E
Device Lot Number71F19K0913
Was Device Available for Evaluation? No
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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