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 20G 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 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Component Missing (2306); Protective Measures Problem (3015)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/23/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascys0152 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (ascys0152) have been reported from the same facility in (b)(4).
 
Event Description
It was reported that the needle protector was not on the needle causing the needle to be exposed and the nurse pricked her finger.It was stated that this occurred twice.This report addresses the first device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key8696905
MDR Text Key148007137
Report Number3006260740-2019-01645
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741047374
UDI-Public(01)00801741047374
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0132075
Device Lot NumberASCYS0152
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-