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

Model Number 0600520

Device Problems Difficult to Flush (1251); Fracture (1260)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

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 sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that two months and fifteen days post chronic catheter placement, the catheter allegedly had flushing problem.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one broviac s/l catheter was returned for evaluation.Gross, visual, tactile evaluation and functional testing were performed.The investigation is inconclusive for the reported difficulty in flushing issue as the exact circumstances at the time of reported event cannot be verified and the sample evaluation results indicating difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.However, the investigation is confirmed for the identified stretched and protrusion issues as ballooning was noted on a portion of the clamping sleeve upon infusion.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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 that two months and fifteen days post chronic catheter placement, the catheter allegedly had flushing problem.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 SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16200679
• MDR Text Key: 307804646
• Report Number: 3006260740-2022-06084
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807
• 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: 03/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600520
• 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: 04/04/2023
• 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