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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER
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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER Back to Search Results
Catalog Number AK-21242-CDC
Device Problem Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: the catheter migrates when the customer gets to icu.The touhy borst connection with the tape for cath gard is not adequate for securing the catheter.Therapy was not delayed or interrupted.
 
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
The customer reports: the catheter migrates when the customer gets to icu.The touhy borst connection with the tape for cath gard is not adequate for securing the catheter.Therapy was not delayed or interrupted.
 
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Brand Name
ARROW MULTI-LUMEN/PSI KIT
Type of Device
INTRODUCER CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8413958
MDR Text Key138791887
Report Number9680794-2019-00083
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K011761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/31/2019
Device Catalogue NumberAK-21242-CDC
Device Lot Number13F18D0242
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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