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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of refs4749 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by healthcare professional "we had a powerglide issue on friday. Went to place, she said the access and wire deployment went in fine without feeling any issues. She went to thread the catheter and it didn't go. Attempted to pull back on the catheter and wire but both were stuck. She pulled everything out entirely and found that the wire was completely bent backwards, and the needle was through the catheter. They did measurements and ensured everything came out. ".
 
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Brand NameFULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12517140
MDR Text Key272886143
Report Number3006260740-2021-03926
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF322088PT
Device Lot NumberREFS4749
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/22/2021 Patient Sequence Number: 1
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