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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 16 CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER PERCUTANEOUS Back to Search Results
Model Number IPN038301
Device Problems Device Contamination with Chemical or Other Material (2944); Suction Failure (4039)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2020
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). It is unknown if the device sample is available for evaluation.
 
Event Description
It was reported that the central line and vascath both inserted into left jugular vein (lij) on (b)(6) 2020. Difficulty using the vascath noted on (b)(6) 2020 with continuous alarms of high pressures and unable to aspirate on one of the ports. Decision to insert new vascath into right internal jugular (rij). On checking the cxr following the new rij line insertion, an opacity was noted distal to the old lij vascath. On removing the old lij vascath the user cut the distal end of the vascath, to discover one port was filled with white plastic looking material. Delay in treatment to due new insertion of cvc.
 
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Brand NameARROW CVC SET: 3-LUMEN 12 FR X 16 CM
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 Key10158367
MDR Text Key195265950
Report Number3006425876-2020-00527
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K862056
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 06/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN038301
Device Catalogue NumberCS-12123-F
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 Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2020
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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