• 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 4FR DL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

  • 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 4FR DL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
It was reported by the customer that patient in the icu had a provena 4f dl midline started leaking where the catheter meets the bifurcation.Concerns were the risk of infection and incomplete delivery of medications.
 
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.H3 other text : device not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4FR DL PROVENA MIDLINE MAX BARRIER KIT
Type of Device
MIDLINE CATHETER
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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key16773335
MDR Text Key313815310
Report Number3006260740-2023-01444
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741154119
UDI-Public(01)00801741154119
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/14/2023
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
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberN/A
Device Catalogue NumberS4254108D
Device Lot NumberREGP4365
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2023
Initial Date FDA Received04/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2022
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;
-
-