MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 POWERPICC; Peripherally Inserted Central Catheter (PICC)

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported picc inserted in (b)(6) 2026 on a child with 3cg.Child was in hospital and found a piece of not sure if stylet or a small piece of picc in the patient.Additional information received on 25-aug the child is currently asymptomatic.An analysis by interventional radiologists and pediatric cardiac surgeons is underway to determine whether it is the best pec.The piccline was installed on (b)(6) and removed on (b)(6) 2026, but the distal metallic end of the guide is still in the intracardiac position.Additional information received on 28-aug the picc was inserted (b)(6) and the metallic fragment was identified on (b)(6).Xrays taken in april and may show the same fragment in the same location.The insertion records indicate the procedure was uncomplicated with no documented issues.P wave guidance was used throughout the procedure and remained functional until the final step, when the guidewire was withdrawn and the picc was trimmed at approximately 25 centimeters for the 10-year-old patient.The chu medical team evaluated three options: leave the fragment in place and monitor with follow-up imaging in 6 months surgical removal via sternotomy (considered high risk) radiologic retrieval through the inferior vena cava the medical team and family have decided to leave the fragment in place with a planned xray for (b)(6).
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 device has not been received by the manufacturer for evaluation.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.

• Brand Name: POWERPICC
• 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 sparks ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50714868
• Report Number: 3006260740-2026-06596
• Device Sequence Number: 15897368
• Product Code: LJS
• UDI-Device Identifier: 00801741034466
• 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 Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1174118
• Device Lot Number: REKS0617
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2025
• 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 Age: 10 YR
• Patient Sex: Unknown