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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8" CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8" CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SA-17702-J
Device Problem Material Separation (1562)
Patient Problem Death (1802)
Event Date 08/13/2020
Event Type  Death  
Manufacturer Narrative

Qn# (b)(4). The sales rep. Attempted to obtain additional information from the user facility. The user facility refused submitting any additional information. 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. Based on the customer report, "self-removal of the catheter by the patient caused damage to one of extension lines," user error likely caused or contributed to this event. However, without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information. Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample. Teleflex will continue to monitor and trend for reports of this nature.

 
Event Description

It was reported: self-removal of the catheter by the patient caused damage to one of the extension lines. The extension line detached from the injection hub, and the relationship is unknown though, the patient was eventually deceased. The user suspects the air embolism became the cause of the patient's death.

 
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Brand NameARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8"
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 Key10488362
MDR Text Key205501506
Report Number3006425876-2020-00769
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberSA-17702-J
Device LOT Number71F19J0182
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2019
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: 09/03/2020 Patient Sequence Number: 1
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