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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 PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Model Number IPN030899
Device Problems Complete Blockage (1094); Material Twisted/Bent (2981)
Patient Problem Death (1802)
Event Date 06/04/2020
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that: involving a covid-19 female patient that was in resuscitation department prior to the incident. During use, the distal catheter extension line twisted in/fold on itself. The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again. No medical intervention was necessary. The patient is deceased , but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid-19 few hours later.

 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
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 Key10158236
MDR Text Key195264827
Report Number3006425876-2020-00521
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN030899
Device Catalogue NumberCV-16702
Device LOT Number71F19K2279
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/16/2020 Patient Sequence Number: 1
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