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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP
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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-26702-E
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "patient who requires advancement of the central catheter, when advancing the guide, it fractures even so, the specialist dilates and advances the catheter, but when withdrawing it, the guide is forced out and damages the catheter".It was reported there were two devices used with the patient.The patient's condition was reported as critical, but the damage to the catheter was unrelated to the patient's condition.It was reported the patient did not have any complications.The patient had to be punctured twice.
 
Event Description
The complaint is reported as: "patient who requires advancement of the central catheter, when advancing the guide, it fractures even so, the specialist dilates and advances the catheter, but when withdrawing it, the guide is forced out and damages the catheter".It was reported there were two devices used with the patient.The patient's condition was reported as critical, but the damage to the catheter was unrelated to the patient's condition.It was reported the patient did not have any complications.The patient had to be punctured twice.
 
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.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7FR X 20CM
Type of Device
CATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11824654
MDR Text Key251432018
Report Number3006425876-2021-00414
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date11/13/2022
Device Catalogue NumberCV-26702-E
Device Lot Number71F20L2643
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age79 YR
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