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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; CATHETER, INTRAVASCULAR, THER
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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; CATHETER, INTRAVASCULAR, THER Back to Search Results
Catalog Number MTO-11142-AJ
Device Problem Difficult to Remove (1528)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Potential lot# - 71f19l2387.
 
Event Description
It was reported that the user had a difficulty in removing the device after 1-day placement in the patient.The user gave the patient a general anesthetic, by which the device could be removed.No injury to the patient was reported.
 
Event Description
It was reported that the user had a difficulty in removing the device after 1-day placement in the patient.The user gave the patient a general anesthetic, by which the device could be removed.No injury to the patient was reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.
 
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Brand Name
ARROW MULTI-LUMEN/PSI KIT
Type of Device
CATHETER, INTRAVASCULAR, THER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9788218
MDR Text Key182021729
Report Number3006425876-2020-00234
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K002507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberMTO-11142-AJ
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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