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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.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
 
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
MDR Report Key7596580
MDR Text Key111003266
Report Number1036844-2018-00167
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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