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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 3006260740-2022-03173
• Device Sequence Number: 17534266
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown