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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PG PRO 18G 10CM BASIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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PG PRO 18G 10CM BASIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Improper or Incorrect Procedure or Method (2017); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Was reported an 18g x 10cm cath with about a cm missing. It was stated that the placer tried to pull the catheter back over the needle which caused the shear. No other information was provided.
 
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Brand NamePG PRO 18G 10CM BASIC
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12411010
MDR Text Key273534600
Report Number3006260740-2021-03648
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
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

Patient Treatment Data
Date Received: 09/01/2021 Patient Sequence Number: 1
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