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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4 FR SL PROVENA MIDLINE BASIC KIT, CE; MIDLINE CATHETER
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C.R. BARD, INC. (BASD) -3006260740 4 FR SL PROVENA MIDLINE BASIC KIT, CE; MIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2023
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 manufacturer has received the sample and will evaluate.Results are expected soon.
 
Event Description
Customer reported that on (b)(6) , the eiav - iv therapy hospital team implants a midline in a patient admitted to geriatrics.The next day the geriatrics department informed the patient that a part had come loose, without further explanation.The piece is the distal luer of one of the two lights, detached from the tube.They kept the line clamped and eiav replaced the catheter immediately.
 
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a detached luer adapter was confirmed and the cause appeared to be related to manufacturing.The product returned for evaluation was one 4fr d/l powermidline catheter.Usage residues were observed throughout the sample.The purple luer adapter was fully detached and was not returned for evaluation.The extension tubes appeared unremarkable, with no deformation and legible printing.Tactile inspection of the sample was unremarkable.Neither extension tube exhibited tensile weakness or plastic deformation.Microscopic inspection of the proximal end of the detached extension tubing revealed a glossy surface consistent with the manufactured end, indicating that the tubing was detached and not broken.The lack of tensile weakness, material deformation and mechanical damage suggested that the luer likely became detached under normal use conditions.This suggested that the bond between the luer and the extension tube may not have been properly formed during device manufacture.Photographs have been forwarded to the manufacturing site for further evaluation.
 
Event Description
Customer reported that on june 22nd, the eiav - iv therapy hospital team implants a midline in a patient admitted to geriatrics.The next day the geriatrics department informed the patient that a part had come loose, without further explanation.The piece is the distal luer of one of the two lights, detached from the tube.They kept the line clamped and eiav replaced the catheter immediately.
 
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Brand Name
4 FR SL PROVENA MIDLINE BASIC KIT, CE
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
suedabba mahboobi
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17312989
MDR Text Key318920244
Report Number3006260740-2023-02908
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K162900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2023
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 NumberS64244118
Device Lot NumberREGT3149
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
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;
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