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

Model Number N/A

Device Problem Failure to Infuse (2340)

Patient Problems Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

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.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "patient developed thrombophlebitis, approximately 15cm phlebitic zone along the basilic vein.Initial midline was occluded, no return flow, a second midline was installed, this time in the cephalic vein.Patient has had outpatient treatment for the thrombophlebitis.Doppler identified the 15cm thrombophlebitis on (b)(6) 2022.".

• Brand Name: BARD MIDLINE
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15472713
• MDR Text Key: 300549553
• Report Number: 3006260740-2022-03699
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141010
• UDI-Public: (01)00801741141010
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• 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: 08/30/2022
• 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