MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported defective introducer.Not used on patient, out of the package was defective.No further information was provided.06/18/2026 it was found during an investigation microscopic inspection of the device found buckling of the sheath edge.
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 damaged microintroducer sheath was confirmed but the exact cause remains unknown.The product returned for evaluation was one 4.5fr microez microintroducer.The returned product sample was evaluated and the tip of sheath was found to be deformed.The following observations were noted during the sample evaluation: no usage residue was seen on the sample, suggesting that the device had been damaged prior to insertion.A longitudinally aligned split was present at the sheath edge.The split had straight and well-defined fracture edges.Buckling and flaring of the sheath edge was present around the split peel-apart sheath deformation was observed that appeared consistent with insertion against resistance; however, the lack of use residues indicated that the device had likely not been inserted into a patient.Buckling of the sheath edge resulting in a crumpled appearance, as seen on this device, is typically a result of the sheath edge catching and pressing against an object.Given that the reported event likely happened prior to insertion, possible contributing factors include mishandling of the device by the user or mishandling during the manufacturing process.The features observed during investigation did not provide enough evidence to conclusively determine when and where the damage occurred or if any other additional factors also contributed to the reported event.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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 sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 25719125
• Report Number: 3006260740-2026-04736
• Device Sequence Number: 18802731
• Product Code: LJS
• UDI-Device Identifier: 00801741130373
• UDI-Public: (01)00801741130373(11)251223(17)270331(10)REKY0148
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 06/23/2026

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 Model Number: N/A
• Device Catalogue Number: S1294108D
• Device Lot Number: REKY0148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2025
• 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