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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number SI-21142
Device Problems Crack (1135); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that during puncturing, aire was aspirated. When the plastic part of needle was investigated it was noted that the needle hub had several cracks. A new cvc was used.
 
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Brand NameARROW MULTI-LUMEN/PSI SET
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
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
keely mckinley
3015 carrington mill blvd
morrisville, NC 27560
9194334889
MDR Report Key8658449
MDR Text Key146654346
Report Number3006425876-2019-00386
Device Sequence Number1
Product Code FOZ
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 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/04/2021
Device Catalogue NumberSI-21142
Device Lot Number71F19C2423
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2019
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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