MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F; CHRONIC CATHETERS

Catalog Number 0600520

Device Problems Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the device is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.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.H3 other text : device pending return.

Event Description

It was reported that sometime post a chronic catheter placement, the part of the catheter in the external part of the body allegedly swelled.Reportedly, the catheter was repaired using a repair kit and was remained in place in the patient.There was no reported patient injury.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F
• Type of Device: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18325317
• MDR Text Key: 330573793
• Report Number: 3006260740-2023-05707
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0600520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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