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

Catalog Number	CK000917
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dilator broke apart when being used in the patient.No patient harm was observed.No other information was provided.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
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 improper peel is confirmed and was determined to be manufacturing related.One 3.5fr microintroducer sheath was returned for evaluation.An initial visual observation revealed the microintroducer t-handle was split in half and the sheath had been peeled.The sheath was observed to be detached from one half of the t-handle.Biological residue was observed on the sample.A microscopic observation revealed some plastic deformation and uneven edges at the break site.The t-handle was observed to have some void areas on the half where the sheath was attached to.These findings suggest the improper peel of the microintroducer sheath was likely caused by inadequate enveloping/bonding of the sheath to the t-handle during the manufacturing process.The reported event was found to be part of a known issue.The manufacturing facility has been notified of this event, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: PROVENA
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24147969
• Report Number: 3006260740-2026-00124
• Device Sequence Number: 8887351
• Product Code: PND
• UDI-Device Identifier: 00801741187827
• UDI-Public: (01)00801741187827(11)250916(17)261231(10)REKV0588
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CK000917
• Device Lot Number: REKV0588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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: Other
• Patient Sex: Unknown