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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 CDC-45703-P1A
Device Problem Insufficient Information (3190)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 02/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information from the user facility was received and stated: the device did not malfunction , and no defect noted. The physician omitted suturing of the device (side wings). The patient did not suffer any long-term effects because of this event.
 
Event Description
According to the medwatch ((b)(4)) "right intrajugular central line dislodged in ct scan when the patient was moved from cart to machine. The hub of the central line remained sutured in place (the catheter clamp and fastener were sutured together into the patient's skin). It was discovered that the side wings of the anchoring device were not sutured/stapled. What did not happen in this case is that the anchoring device was not sutured to the patient's skin. It was reported that when the blue securement device is sutured in place, it may visibly hide or disrupt the view of the anchoring device, and resulting (as in this case), the md omitting to suture the anchor piece in place. The patient was on large amounts of pressors at the time and patient's blood pressure decreased to 49/43. Epinephrine was required and patient was given 20-gauge piv in order to maintain blood pressure. Follow up with providers who inserted the central line and neither believes the central line kits need to be changed at this time. The physician who inserted the line received feedback regarding central line insertion. The nursing role for dressing and securement dressings were appropriate for the patient's central line and placed per our procedure. Nursing recalled that this issue (not suturing the anchor device) has occurred previously by a few different providers. They question if there is a design issue that plays a role in this omission".
 
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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 INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9996148
MDR Text Key188849759
Report Number9680794-2020-00188
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,use
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCDC-45703-P1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/24/2020 Patient Sequence Number: 1
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