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

Model Number	N/A
Medical Device Problem Codes	Product Quality Problem (1506); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by medwatch that the bd provena midline catheter internal stiffening stylet appears to have a residue/substance present on newly opened sterile product; possibly shearing from t-lock assembly.This was on a newly opened package and was not used on a patient.Residue was noted on the internal guidewire when attempting to pull back after trimming the midline.
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 foreign material on the stylet is confirmed but the root cause remains unknown.The product returned for evaluation was one 3fr sl provena midline catheter w/ t-lock assembly and hydrophilic stiffening stylet.A gross visual inspection of the returned unit found that the stylet had a white substance scattered along the length of the stylet.Inspection of the white substance under a microscope found that the material appeared bunched and peeling.Additionally, the material appeared to partially coat the stylet wire.The observed features indicated that the substance was likely the hydrophilic coating applied to the stylet during manufacturing.The coating was delaminated; however, the investigation did not identify any evidence to determine what caused the delamination of the coating.Potential factors which may have contributed to the observed defect include exposure to incompatible chemicals, unidentified environmental factors affecting the properties of the coating, withdrawal of the stylet through a dry t-lock prior to flushing the system, and withdrawal of the stylet across the edge of the t-lock body.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23708175
• Report Number: 3006260740-2025-09240
• Device Sequence Number: 16109287
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076(11)250722(17)260831(10)REKS3144
• Combination Product (Y/N): Y
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REKS3144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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