MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/24/2022

Event Type  Injury  

Event Description

It was reported "the guidewire became stuck in the vein, and after removal fragments remained in the patient¿s tissue.The sequence of events are as follows: cephalic vein was attempted twice by the 1st vascular access nurse.Basilic vein attempted in the same arm.Gained access with needle and attempted guidewire.Guidewire would not advance, attempted to pull out both needle and wire together, wire came out a little bit but then would not budge.Guidewire was in arm approximately 2 cm.Applied heat, asked for ativan po which was administered, also asked for surgery consult.Surgeon pulled out wire at bedside,  guidewire came out with tip frayed, surgeon ordered an xray for fragments.  us was done to check vessel.Xray revealed tiny fragment in arm, approximately 0.2-0.4 cm in length (in estimation).Patient did receive her mri successfully without complications.".

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regq0632 showed no other similar product complaint(s) from this lot number.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15224947
• MDR Text Key: 297885963
• Report Number: 3006260740-2022-03173
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REGQ0632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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): Required Intervention