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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN031155
Device Problem Crack (1135)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Qn#: (b)(4).

 
Event Description

Customer reported that during placement of a subclavian cvc on an obese patient (due to thrombosis of various other veins the subclavian was the only access), the needle of the above-mentioned 4-lumen cvc broke between the plastic part and the needle after contact with the clavicle. The breakage occurred during the attempt to come underneath clavicle.

 
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Brand NameCVC SET: 4-LUMEN 8.5FR X 20CM
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 Key9458001
MDR Text Key179433400
Report Number3006425876-2019-01040
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
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 12/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN031155
Device Catalogue NumberDE-15854-S
Device LOT NumberUNKNOWN
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 Received01/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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