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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 2FR SL W/O GW BULK NON; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 2FR SL W/O GW BULK NON; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Phlebitis (2004)
Event Date 12/11/2023
Event Type  Injury  
Event Description
It was reported, "development of msd phlebitis in the nb, possibly related to the medical device used, given that proper aseptic techniques were used during the procedure, as well as the fact that it was an easy procedure to perform, with no complications and without the need to pull/movement the device." additional information received 18 january 2024: presence of phlogistic signs in the catheter path in the first few days after insertion in the newborn, causing phlebitis.We would point out that the processes have already been reviewed and no faults have been identified.The picc had to be removed and changed.Impatient stays were prolonged for some of the patient.The procedures are carried out exclusively by nurses who have been trained by the institution to carry out this procedure.
 
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned 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.
 
Event Description
It was reported, "development of msd phlebitis in the nb, possibly related to the medical device used, given that proper aseptic techniques were used during the procedure, as well as the fact that it was an easy procedure to perform, with no complications and without the need to pull/movement the device." additional information received 18 january 2024: presence of phlogistic signs in the catheter path in the first few days after insertion in the newborn, causing phlebitis.We would point out that the processes have already been reviewed and no faults have been identified.The picc had to be removed and changed.Impatient stays were prolonged for some of the patient.The procedures are carried out exclusively by nurses who have been trained by the institution to carry out this procedure.Additional information received feb 15 2024 : the patients involved in these complaints were admitted to the neonatal icu, i.E.Patients who were already in serious condition and taking medication.The team noted the presence of phlogistic signs in the catheter pathway in the first few days after insertion, causing phlebitis.The picc had to be removed.Some patients required up to three picc changes.It should be noted that phlebitis contributed to prolonged hospitalization, but as the patients already had severe conditions, it is not possible to measure the patients whose hospitalization was prolonged exclusively due to the use of this material.The medicines in use were reviewed, the processes were reviewed and no faults were identified.
 
Manufacturer Narrative
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.
 
Event Description
It was reported, "development of msd phlebitis in the nb, possibly related to the medical device used, given that proper aseptic techniques were used during the procedure, as well as the fact that it was an easy procedure to perform, with no complications and without the need to pull/movement the device." additional information received 18 january 2024: presence of phlogistic signs in the catheter path in the first few days after insertion in the newborn, causing phlebitis.We would point out that the processes have already been reviewed and no faults have been identified.The picc had to be removed and changed.Impatient stays were prolonged for some of the patient.The procedures are carried out exclusively by nurses who have been trained by the institution to carry out this procedure.Additional information received feb 15 2024 the patients involved in these complaints were admitted to the neonatal icu, i.E.Patients who were already in serious condition and taking medication.The team noted the presence of phlogistic signs in the catheter pathway in the first few days after insertion, causing phlebitis.The picc had to be removed.Some patients required up to three picc changes.It should be noted that phlebitis contributed to prolonged hospitalization, but as the patients already had severe conditions, it is not possible to measure the patients whose hospitalization was prolonged exclusively due to the use of this material.The medicines in use were reviewed, the processes were reviewed and no faults were identified.
 
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Brand Name
2FR SL W/O GW BULK NON
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18717732
MDR Text Key335521824
Report Number3006260740-2024-00562
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberSA5167436B
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
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