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	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, picc placed in right upper arm brachial vein, trimmed to 47 cm with 2 cm out to use securacath as stabilization device.Placed at 1245 pm and at 0430 pm the line was reported as hard to flush unless retracted from insertion site.8/27 it was reported that the line did not have blood return, line was removed and replaced.X-ray of the arm shows major z-tracking/kink in line and after removal, kinks seen at 9 cm and 11 cm.Picc replaced.
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.
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 catheter kinking is confirmed and was determined to be use-related.One 5 fr d/l powerpicc catheter was returned for evaluation.An initial visual observation of the catheter returned revealed blood residues along the device.A faint, circumferential kink impression was observed at the 11 cm depth marker.Microscopic inspection of the returned device revealed two kinks along the catheter shaft: one at the 9 cm depth marker and one at the 11 cm depth marker.Functional testing of both lumens revealed the device was patent to infusion and aspiration.No difficulty or resistance was observed during functional testing.The catheter placement, securement, maintenance, and access techniques may have contributed to the observed kinks.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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23065415
• Report Number: 3006260740-2025-06951
• Device Sequence Number: 13228161
• Product Code: LJS
• UDI-Device Identifier: 00801741155055
• UDI-Public: (01)00801741155055(11)250527(17)260430(10)REKR0292
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: S1274108D4
• Device Lot Number: REKR0292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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