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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB CATHETER INTRAVASCULAR THERAPE

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ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB CATHETER INTRAVASCULAR THERAPE Back to Search Results
Model Number IPN035564
Device Problem Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/29/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report number mw5102225.
 
Event Description
Complaint found in maude database reported as: "a right ij triple lumen catheter was inserted in a pt with severe sepsis. At the conclusion of the procedure, it was noted the guidewire was retained within the catheter and partially in the ivc. The catheter was not free-floating and was successfully retrieved by ir. Unfortunately, guidewires have a known design "flow" in that there was no hard-stop design measures, other than the professional user, to prevent a guidewire from 'slipping away' into the catheter itself. ".
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
Type of DeviceCATHETER INTRAVASCULAR THERAPE
MDR Report Key12302964
MDR Text Key265875874
Report Number1036844-2021-00146
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 health professional,other
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN035564
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number23F20K0126
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2020
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: 08/10/2021 Patient Sequence Number: 1
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