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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported by healthcare professional "the wire was coiled up very badly. Powerglide placement was normal. Nurse is very experienced with accucath and powerglide. " no other information was provided.
 
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Brand Name18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12629129
MDR Text Key276390177
Report Number3006260740-2021-04360
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
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF118100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/13/2021 Patient Sequence Number: 1
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