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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional 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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer rn was placing a midline for a pediatric patient and after gaining access and threading the wire they met resistance.After attempting to retract the wire it would not retract from the needle.Rn did remove the needle over the wire however they were still unable to pull back the wire.X-rays were taken and it was observed that the wire twisted a knot which is why it would not come out of the skin/vein.Additional information: the patient was taken to the or for a cutdown procedure in order to remove the knotted guidewire.While the patient was sedated, they also placed a sc tlc for the patient to get central access.
Additional 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.
Additional 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 knotted guidewire is confirmed and was determined to be use related.One photograph and one radiograph of a guidewire were returned for evaluation.An initial visual observation of the photograph showed the guidewire was knotted near the distal tip of the device.The guidewire was kinked approximately two centimeters proximal from the knot.The radiograph shows what appears to be the knotted guidewire inserted into the patient¿s arm.The knot in the distal end of the guidewire was likely caused by repeated advancement and retraction of the guidewire against resistance within the vessel, likely during twisting.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: PROVENA MIDLINE
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21877731
• Report Number: 3006260740-2025-02475
• Device Sequence Number: 7653795
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076(11)240812(17)251130(10)REJT1306
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2025

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 Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REJT1306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 04/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/22/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: 14 MO
• Patient Sex: Male
• Patient Weight: 9 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American