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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW INTRODUCER, CATHETER

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TELEFLEX INCORPORATED ARROW INTRODUCER, CATHETER Back to Search Results
Model Number IPN036335
Device Problem Material Discolored (1170)
Patient Problem Insufficient Information (4580)
Event Date 07/22/2022
Event Type  malfunction  
Event Description
Discoloration of distal tip of cordis.
 
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Brand NameARROW
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd.
morrisville NC 27560
MDR Report Key15224687
MDR Text Key297891474
Report Number15224687
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10801902112962
UDI-Public(01)10801902112962
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN036335
Device Catalogue NumberASK-21242-VCU
Device Lot Number13F22D0706
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2022
Event Location Hospital
Date Report to Manufacturer08/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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