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

Catalog Number	1194108D
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, picc line placement by our picc line nurse.Placed without difficulty.When she attempted to withdraw the guidewire with gentle pulling, it was noted to be ¿stuck¿.Catheter withdrawn while simultaneously attempting to gently withdraw guidewire.Once picc line out, guidewire was noted to have fraying at the tip.Tourniquet was tightened and pressure held at insertion site while notifying ir team.Fluoroscopy evaluation demonstrated approximately 3 cm long guidewire 0.018 size in mid arm.Based on radiographic assessment, the fractured wire appeared to be deeper than subcutaneous tissues and may have retracted from the insertion site near the brachial or basilic vein.There is very low likelihood this small, retained wire fragment, will be associated with symptoms or significant future complications.Chest xray was completed to assess for wire fragments and possible embolization in the chest.X-ray negative.Vascular surgery consulted.They have not seen the patient yet.Additional information provided january 21: after the consult, it was decided to leave it in the patient.
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.
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 frayed stylet was confirmed and determined to be use related.The product returned for evaluation was one 4fr sl powerpicc solo catheter w/ t-lock assembly and 3cg stylet.A gross visual inspection of the returned unit found that the polyimide region of the stylet had fully fractured.Microscopic inspection of the stylet fracture site found that polyimide had sharply formed fracture edges and the facture surface had striations present.The observed features were consistent with damage caused by contact with a sharp edged instrument, suggesting that the stylet may have been cut when the catheter was trimmed to length.An examination of the stylet structure revealed no potential damage/defect related to manufacture of the product.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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24176906
• Report Number: 3006260740-2026-00162
• Device Sequence Number: 9557807
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510(11)250722(17)260831(10)REKT0249
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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
• Report Date (Section B): 03/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 1194108D
• Device Lot Number: REKT0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: Required Intervention
• Patient Sex: Unknown