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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Phlebitis (2004); Swelling/ Edema (4577)

Event Date 11/28/2023

Event Type  Injury  

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.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.

Event Description

It was reported development of phlebitis (inflammation in veins) in newborn using this material.Right lower limb, where the central picc catheter is implanted, has a fibrous cord, edema and hyperemia.A phlebitis protocol has been carried out.It was only necessary to remove and replace the picc.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 changed.Impatient stays were prolonged.The procedures are carried out exclusively by nurses who have been trained by the institution to carry out this procedure.The procedure 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.

Event Description

It was reported development of phlebitis (inflammation in veins) in newborn using this material.Right lower limb, where the central picc catheter is implanted, has a fibrous cord, edema and hyperemia.A phlebitis protocol has been carried out.It was only necessary to remove and replace the picc.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 changed.Impatient stays were prolonged.The procedures are carried out exclusively by nurses who have been trained by the institution to carry out this procedure.The procedure carried out exclusively by nurses who have been trained by the institution to carry out this procedure.Additional information received on 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 a longer hospital stay, but as the patients already had severe conditions, it is not possible to measure the patients whose hospital stay was prolonged exclusively by the use of this material.The medicines in use were reviewed, the processes were reviewed and no faults were identified.As the patients already had serious conditions, it is not possible to measure the patients whose hospitalization was prolonged exclusively by the use of this material.

• 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 Key: 18712935
• MDR Text Key: 335524741
• Report Number: 3006260740-2024-00541
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SA5167436B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/04/2024
• 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 Number: 1
• Patient Outcome(s): Required Intervention