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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-15402-E
Device Problem Material Rupture (1546)
Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)
Event Date 06/26/2019
Event Type  Death  
Manufacturer Narrative
(b)(4).Additional information received from user facility: cause of death not specified and not associated with this event.The customer reports the death was not associated with the device.A medical intervention was required, the issue with the device was not associated with this event.The event was reported by a healthcare pharmacist since the event reported as a non-serious adverse.
 
Event Description
The customer reports: during the insertion of the catheter it is notice that the swg (spring wire guide) ruptures, leaving metallic filament embedded in the patient.Rx is performed and is evidence a possible metallic piece in the cervical zone.
 
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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The customer reports: during the insertion of the catheter it is notice that the swg (spring wire guide) ruptures, leaving metallic filament embedded in the patient.Rx is performed and is evidence a possible metallic piece in the cervical zone.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 4 FR X 8 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8856946
MDR Text Key153147003
Report Number9680794-2019-00289
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue NumberCS-15402-E
Device Lot Number14F18M0135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/02/2019
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; Other; Required Intervention;
Patient Age5 MO
Patient Weight6
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