Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/12/2019
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 asdtf044 showed no other similar product complaint(s) from this lot number.
 
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 0.75IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9627667
Report Number3006260740-2020-00293
Device Sequence Number14150865
Product Code FPA
UDI-Device Identifier00801741047497
UDI-Public(01)00801741047497
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K153440
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/24/2020
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 Number0142275
Device Lot NumberASDTF044
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/03/2020
Initial Report FDA Received Date01/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-