MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported, patient admitted 23 days ago had a central jugular catheter with no signs of inflammation, on antibiotics.At the request of the infectious disease specialist, a catheter replacement was requested yesterday afternoon.An unsuccessful attempt was made by a nurse, doctor, and nursing technician throughout the procedure, and the mother was consulted at the end.After the procedure, the patient complained of pain in the limb, mainly at the puncture site, and a warm compress was applied.This morning, the pain persisted, and the pediatric surgeon requested a chest ct scan to examine the lung after removal of the drain, with a central catheter replacement scheduled in the operating room.The ct scan showed an object in the msd, described as a catheter, and a review of the image and report was requested, which suggested that it was the guide wire, since the picc had not been inserted.The nurse and doctor reported that the guide wire and catheter had not progressed.They stated that they had discarded the guide wire, but it was still inside the patient.The patient returned to the operating room at around 5 p.M., and the guide wire was removed, measuring 50 cm, by puncture in the right femur, and a picc was inserted in the mse.An ultrasound of the msd was performed yesterday with no changes.The patient is doing well.
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 migrated guidewire was confirmed but the exact cause and circumstances surrounding how that occurred were unknown.The product returned for evaluation was one nitinol guidewire.A gross visual inspection of the returned sample found that no fracture or unraveling of the guidewire was present.Use residues throughout the guidewire and a small degree of bending at the distal end of the guidewire were observed.The guidewire was microscopically inspected but no remarkable features were observed.The overall state of the sample was unremarkable.Based on the available evidence the cause of the customer's reported event was ultimately unknown.
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 damaged guidewire is inconclusive due to the state of the returned sample.One photograph of a guidewire was returned for evaluation.An initial visual observation of the photograph showed what appears to be a guidewire.Neither end of the guidewire could be seen clearly in the returned photograph, and no obvious damage could be seen on the sample in the returned photograph.Additionally, it was not possible to verify the root cause of the guidewire reportedly escaping into the patient¿s vasculature from the returned photograph.Inspection of the returned photograph was insufficient to identify the alleged issue or a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2, 3CG
• 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: 22512116
• Report Number: 3006260740-2025-04833
• Device Sequence Number: 21016772
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633(11)240412(17)250731(10)REJP2041
• 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,Followup
• Report Date (Section B): 09/11/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1295118
• Device Lot Number: REJP2041
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 09/11/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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: Required Intervention
• Patient Sex: Unknown