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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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.
Event or Problem Description
It was reported that the catheter placement has been inaccurate with the 3cg confirmation.Many times, the catheter will show perfect placement with the 3cg sherlock, but subsequent chest x-rays will show the picc tip mid svc instead of distal svc or cavo atrial junction.A specific number of affected devices or patients was not provided by the complainant.
Event or Problem Description
Additional information: associated patient(s) had xrays done the next morning in the icu.There have been no known injuries.One picc was repositioned last year due to the picc tip ending in the proximal svc.Patient was to receive a vesicant with osmolarity greater than 900.
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.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2025-07645 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2025-07830.

• Brand Name: POWERPICC SOLO2
• Common Device Name: PERIPHERALLY INSERTED CENTRAL 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: 23267422
• Report Number: 3006260740-2025-07645
• Device Sequence Number: 10146382
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510(11)230711(17)240731(10)REHT0623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/24/2025

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1194108D
• Device Lot Number: REHT0623
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 10/23/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2023
• 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