MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/25/2023

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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned.

Event Description

It was reported by the customer "the patient has a middline - a bi-directional valve - a 3-way bd extender and a tubing with dialaflow connected to a vein guard.I performed my pulse flush as close as possible to the patient on the extender tap.During the pulse rinse, a leakage appeared before the thread of the extension.This is the second time this has happened in my department." immediate action(s) taken after the event: change the device with the patient.No injury or damage reported.Customer response for follow-up: the customer advised after discussion with the healthcare team, it would ultimately be a case of misuse.Indeed, the cracks are probably due to an overpressure problem during rinsing.The customer is closing the file on their side.It was reported this occurred on two occasions.This report addresses the first occurrence.

• Brand Name: BARD MIDLINE
• Type of Device: BARD MIDLINE
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18317379
• MDR Text Key: 330572685
• Report Number: 3006260740-2023-05687
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• 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): Other