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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER

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SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383313
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1053935, medical device expiration date: 2025-02-28, device manufacture date: 2021-03-17. Medical device lot #: 1053923, medical device expiration date: 2025-02-28, device manufacture date: 2021-03-09. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that saf-t-intima w/y adapter yel 24ga x. 75i was damaged. The following information was provided by the initial reporter: it was reported by the health professional the current box is not functioning correctly.
 
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Brand NameSAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12136381
MDR Text Key260983437
Report Number9610847-2021-00312
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383313
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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