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: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 25MM; 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
 

C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 25MM; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 11/13/2023
Event Type  malfunction  
Event Description
It was reported that the needle guard came loose when the port was pulled out and the employee pricked herself superficially.Immediate action taken by the hospital / caretaker relevant to the care of the patient.Wound disinfected and needle separated.The incident happened after use on a patient.No other information was provided.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of detachment of the needle safety is confirmed and was determined to be manufacturing related.The product returned for evaluation was a powerloc ez infusion set.The needle housing and bio-bag safety mechanism were returned separated.Use residue was observed on the device.Microscopic inspection of the bio-bag safety mechanism revealed the seal on the distal end of the bag had opened.Microscopic inspection of the needle bevel revealed evidence of use but no damage was observed.The open seal on the bio-bag safety mechanism was caused by detachment of the biobag, likely due to the manufacture of the device.The investigation has been forwarded to the manufacturing site for further investigation.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings in section h:11.
 
Event Description
It was reported that the needle guard came loose when the port was pulled out and the employee pricked herself superficially.Immediate action taken by the hospital / caretaker relevant to the care of the patient.Wound disinfected and needle separated.The incident happened after use on a patient.No other information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EZ HUBER 19G X 25MM
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
maddy vincent
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18271575
MDR Text Key329807918
Report Number3006260740-2023-05513
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K071846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberSHG19-100
Device Lot NumberREGV1206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-