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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	09/16/2025
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 on 09/16, during a picc catheter insertion procedure involving the patient in question, there was a non-compliance with the part called ¿dilator,¿ which caused a significant failure in the procedure, forcing the team to suspend it.The problem occurred in the last stage of the catheter installation process, which was already in place and stabilized with good flow and reflux, after the x-ray was performed, at the moment when the dilator is broken in half for removal.During compression of the blades, one of them was fractured, forming a small loop that wrapped around the catheter and compressed it violently, causing a bend in the device.Team members attempted to rescue the catheter by cutting the loop, but it was already damaged and presented considerable resistance to infusion.By consensus, the team opted to remove it and reschedule the installation of a new device at a later date.Unfortunately, the patient had to undergo difficult venipunctures to conduct the prescribed therapy.There was no direct or serious harm to the patient, but there was harm resulting from the failure of the procedure.There was no prolonged hospitalization or need for changes in the therapeutic approach or prognosis, as the team scheduled a new procedure 48 hours after the event, which was successfully completed.The only intervention needed was monitoring of the puncture site to assess any complications inherent to the procedure itself.The material was not preserved due to the presence of blood residue.
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 an uneven break is confirmed, and the cause was determined to be manufacturing related.Two photographs of a micro introducer were returned for evaluation.The complaint of an uneven break was confirmed.An initial visual observation of the photographs showed one half of the t-handle, and a small ring of orange plastic was observed which indicated an uneven break occurred.This event was determined to be related to a manufacture condition.The investigation was forwarded to the manufacturing facility for further evaluation.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23292500
• Report Number: 3006260740-2025-07734
• Device Sequence Number: 4889497
• Product Code: LJS
• UDI-Device Identifier: 00801741034527
• UDI-Public: (01)00801741034527(11)250118(17)260531(10)REKN1374
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1194118
• Device Lot Number: REKN1374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2025
• 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