MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Catalog Number	1194118
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that when they went to change pt's picc drsg and caps, after removing dressing, tubing appeared to have a kink 8mm under the securacath between the securacath and the luer lock.Pt describes his picc as very "positional" and states that when he went down for a ct scan a while ago the line started leaking when the team was pushing contrast.Customer attempted to straighten kink using sterile technique prior to cleaning in order to resolve resistance that may have been positional or due to kink in line.Kink straightened - drsg change and caps completed.Flushed line with blood return and some saline solution appeared to leak around kink site.Pressed dressing firmer around line and leakage stopped - flushing well with blood return.Customer revisited pt with buddy nurse to reassess line and attempt flushing again.Leakage all around line.Doctor paged and order put in for picc removal.Pt hesitant to remove line as he requires anti-emetics but customer explained that leakage is an infection hazard and there is the potential for air re-entry which is a concern.Pt agreeable to line removal and to piv insertion for prn medications.Picc removed at 1440h.Pt experiencing no chest pain or other concerns at this time.No apparent harm.
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.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.

• Brand Name: POWERPICC SOLO2
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 25524209
• Report Number: 3006260740-2026-04135
• Device Sequence Number: 10741388
• Product Code: LJS
• UDI-Device Identifier: 00801741034527
• UDI-Public: (01)00801741034527(11)240929(17)260131(10)REJW1999
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 01/31/2026
• Device Catalogue Number: 1194118
• Device Lot Number: REJW1999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2024
• 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 Sex: Unknown