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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number ASK-45703-PPHPB
Device Problems Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem Death (1802)
Event Date 01/01/2018
Event Type  Death  
Manufacturer Narrative
(b)(4).The user facility was contacted (via emails and phone) to obtain additional information regarding the event.The user facility could not confirm if the device caused or contributed to the patient's death.The user facility could not confirm if the patient's preexisting conditions caused or contributed to the patient's death.Note: medwatch (from customer) documents the date of patient death as (b)(6) 2018.Teleflex will use (b)(6) 2018 as date of patient death on the medwatch form.
 
Event Description
According to the medwatch ((b)(4)) "during a cardiac resuscitation, doctor attempted central line placement in the patient's right femoral vein.When feeding the guidewire, the wire unraveled in the patient.She had difficulty removing from the patient.Patient required another femoral line to be placed in left femoral vein".
 
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
According to the medwatch ((b)(4)) "during a cardiac resuscitation, doctor attempted central line placement in the patient's right femoral vein.When feeding the guidewire, the wire unraveled in the patient.She had difficulty removing from the patient.Patient required another femoral line to be placed in left femoral vein".
 
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Brand Name
ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+
Type of Device
CATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7313873
MDR Text Key101516156
Report Number1036844-2018-00082
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue NumberASK-45703-PPHPB
Device Lot Number23F17C0534
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2018
Initial Date FDA Received03/05/2018
Supplement Dates Manufacturer Received04/02/2018
Supplement Dates FDA Received04/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age85 YR
Patient Weight138
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