MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVENA MIDLINE 3FR SL PROVENA MIDLINE FULL 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	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw1458 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "when the picc line was being removed the guide wire became stuck, and when it was removed the wire was frayed and the j tip had been lost.This fraying occurred distally along the guidewire very high up the humerus and the care provider did not feel that excessive force was used in advancing or retracting the guidewire.Radiology confirmed the retained guidewire fragment and determined that due to its small size, it was not clinically significant and risks inherent to attempted removal would outweigh any benefit." additional information received 03/29/2022: a detailed description of the placement: placed on or after (b)(6) 2022 in the right humerus after unsuccessful midline catheter placement.How was the break and/or retained segment discovered? are radiographic images available? x-ray.No images available.What type of imaging was used to verify broken piece in patient? are pictures available? x-ray.No images available.What type of catheter securement was utilized? n/a; as the broken piece was the guidewire.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.No patient harm.Any long-term patient harm? no long term patient harm."retained piece of guidewire was determined to be in soft tissue, was not considered clinically significant, and the risk of removal outweighed the potential harm of leaving it in place.".

• Brand Name: DOT PROVENA MIDLINE 3FR SL PROVENA MIDLINE FULL 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14054019
• Report Number: 3006260740-2022-01211
• Device Sequence Number: 14640829
• Product Code: PND
• UDI-Device Identifier: 00801741153990
• UDI-Public: (01)00801741153990
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S4153108BP
• Device Lot Number: REFW1458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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 Age: 65 YR
• Patient Sex: Male