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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

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C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; 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 02/17/2023
Event Type  malfunction  
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.Device not returned.
 
Event Description
It was reported by customer that when placed a midline on 2/9 and it started leaking and needed replacement on 2/17.The catheter was removed and replaced.
 
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Brand Name
3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
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 Key16773039
MDR Text Key313632443
Report Number3006260740-2023-01447
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741154003
UDI-Public(01)00801741154003
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153393
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 04/08/2023
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 Date02/29/2024
Device Model NumberN/A
Device Catalogue NumberS4153108BDP
Device Lot NumberREGZ2082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2023
Initial Date FDA Received04/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2022
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;
Patient Age48 YR
Patient SexMale
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