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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
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, vascular access nurses requested to assess a triple lumen picc line that was "leaking at the bifurcation." line had chg dressing intact with some drainage.Secure-a-cath in place with catheter out 3+cm.Grey lumen was flushed, and fluid was noted to be leaking out from under dressing.When dressing was removed, picc line was noted to be kinked right above the hub, but 1cm below the secure-a-cath.When the line was straightened it was noted to be torn where it was kinked.Consulted provider to discuss whether the picc needed to be replaced for continued central access.Provider said that 2 pivs would be sufficient for the patient.Picc removed without incident.
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 leaking catheter was confirmed.The product returned for evaluation was one 5fr tl powerpicc catheter.The unit was leak tested by flushing the catheter with water using a 12ml luer lock syringe.During testing, a leak was observed on the catheter tubing just distal of the molded joint.Microscopic inspection of the leak site found that a longitudinally aligned, arc-shaped tear was present on the catheter tubing.The fracture edges were angular and the surface was found to be granular.The fracture edge definition suggested that the damage had developed quickly as opposed to the constant wear over time associated with rounded edges.Potential root causes include handling of the catheter with a blunt instrument; however, the features ultimately did not provide enough evidence to conclusively determine a root cause.Therefore, the root cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.
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.

• Brand Name: POWERPICC HF CATHETER
• 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: 23006508
• Report Number: 3006260740-2025-06727
• Device Sequence Number: 13223615
• Product Code: LJS
• UDI-Device Identifier: 00801741085710
• UDI-Public: (01)00801741085710(11)240906(17)260131(10)REJU3499
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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,Followup
• Report Date (Section B): 10/20/2025

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1385118Q
• Device Lot Number: REJU3499
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 10/20/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Female