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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARTERIAL CATH. SET: 20 GA X 8CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARTERIAL CATH. SET: 20 GA X 8CM CATHETER PERCUTANEOUS Back to Search Results
Model Number IPN037640
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The complaint is reported as: "the arterial catheter is not properly working. The catheter was inserted on (b)(6) 2020 at 5pm. On the (b)(6) 2020 at 8am there was : no measurement curve, no sample possible to make. Consequence: no possibility to perform a hemodynamics monitoring. Patient was there for monitoring the blood gas. The care are painful for patients in rescucitation department. " additional information was requested, but was not received at the time of this report.

 
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Brand NameARTERIAL CATH. SET: 20 GA X 8CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10578087
MDR Text Key208555956
Report Number3006425876-2020-00821
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberIPN037640
Device Catalogue NumberSAC-00820-PBX
Device LOT Number71F20A2637
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/04/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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