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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DOT PG PRO 20G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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DOT PG PRO 20G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/19/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr0346 showed no other similar product complaint(s) from this lot number.
 
Event or Problem Description
It is was reported the health professional inserted a powerglide catheter; when she went to flush, it leaked at the hub.
 
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Brand Name
DOT PG PRO 20G 10CM FULL
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12455502
Report Number3006260740-2021-03774
Device Sequence Number3964225
Product Code FOZ
UDI-Device Identifier00801741110580
UDI-Public(01)00801741110580
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
K153280
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberF120101
Device Lot NumberREFR0346
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/19/2021
Initial Report FDA Received Date09/10/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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