MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER BASIC KIT

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported, ¿before dressing the midline catheter, the operator had noticed that the catheter was sectioned at the pre-welded connection with the tabs for fixation.The operator clamped and extracted the catheter, avoiding the risk of embolization.Additional information received 02/20/2024: it was reported, ¿there were no adverse consequences for patient.The catheter dressing procedure is carried out with all precautionary measures in place to avoid contact with body fluids by the healthcare worker.Required replacement of ruptured catheter.".

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 received.

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 complaint of a break in the catheter is confirmed and was determined to be use related.One 3 fr s/l power midline catheter was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned catheter.The catheter was broken just distal of the molded suture wings.An object, presumably catheter dressing, appeared attached to the proximal end of the catheter.A tactile evaluation of the catheter shaft revealed some tensile weakness along the catheter shaft.A microscopic observation revealed an uneven, circumferentially aligned fracture surface at the break site for both the proximal and distal break fracture surfaces.Small fractures were observed on the fracture surfaces of the distal break site.The fracture edges were sharp and uneven.The break site exhibited characteristics associated with tensile failure of the device, or excessive pulling of the catheter.The complaint of a catheter break is confirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported, ¿before dressing the midline catheter, the operator had noticed that the catheter was sectioned at the pre-welded connection with the tabs for fixation.The operator clamped and extracted the catheter, avoiding the risk of embolization.Additional information received 02/20/2024: it was reported, ¿there were no adverse consequences for patient.The catheter dressing procedure is carried out with all precautionary measures in place to avoid contact with body fluids by the healthcare worker.Required replacement of ruptured catheter.".

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT
• Type of Device: MIDLINE CATHETER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18906056
• MDR Text Key: 337689859
• Report Number: 3006260740-2024-01093
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: P6153118
• Device Lot Number: REGZ1427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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
• Patient Age: 67 YR