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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Model Number IPN030093
Device Problem Obstruction of Flow (2423)
Patient Problems No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The customer report of a blocked catheter was confirmed by complaint investigation of the returned sample. The catheter contained a significant amount of biological material build up in the catheter. A device history record review was performed on a potential lot number with no relevant findings. Based on the condition of the sample received, unintentional user error caused or contributed to this event. Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
Customer reported "catheter had to be removed 10 hours before, because a structure (possibly tissue) was deposited inside the catheter and the catheter was blocked". It was reported the catheter was in place for four days. The patient was reported to be critical prior to insertion of the catheter and suffering from multiorgan collapse and sepsis. It was reported therapy was stopped and no blood return was possible. Dialysis was delayed and patient required a blood transfusion due to the delay. A new device was planned to be placed. The patient's condition was reported to be fine at the time of this report.
 
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Brand NameARROW CVC SET: 3-LUMEN 12 FR X 20 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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
victoria sandlin
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key10720670
MDR Text Key212560022
Report Number3006425876-2020-00894
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K970864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN030093
Device Catalogue NumberCS-15123-F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
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: 10/22/2020 Patient Sequence Number: 1
Treatment
NONE REPORTED.
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