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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number ASK-45703-PSJR
Device Problems Break (1069); Sticking (1597)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Patient's current condition is reported as fine.
 
Event Description
The customer reports: triple lumen was attempted in left ij in emergency room. The guidewire was stuck after passing through needle. Needle and wire were removed but piece of wire remained in patient. It was not determined until after the procedure that wire had broken. Access was obtained in another site. Intervention required: surgery to remove the separated swg.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7596580
MDR Text Key111003266
Report Number1036844-2018-00167
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberASK-45703-PSJR
Device Lot Number23F18A0547
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2018
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: 06/13/2018 Patient Sequence Number: 1
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