MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD PICC; 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	05/21/2025
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.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, catheter was inserted into a pediatric patient on (b)(6), and today, during a routine x-ray, a foreign object was identified in the heart chamber.The child will undergo catheterization this afternoon, a cardiac catheterization will be performed for removal.Patient is currently stable.No other information was provided.
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.
Event or Problem Description
Additional information received on june 18, 2025: child underwent picc catheter placement on (b)(6) for antibiotic therapy in the picu.Catheter control x-ray did not show any objects (partially covered by electrode).On the x-ray taken on (b)(6) for discharge control, an object was identified.Venous catheterization was performed on (b)(6) with successful removal of foreign bodies, which appear to be guidewire fragments.Procedure without complications.
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 broken stylet was confirmed but the cause is unknown.A frontal chest radiograph and a photograph of the implicated 3cg wire fragment were returned for evaluation.The chest radiograph showed a right-sided catheter present with the tip over the svc.A small foreign material, consistent with a 3-4cm long wire fragment, was seen overlaying the left heart/lower lobe pulmonary artery.The photograph was of a wire fragment consistent with a 3gc stylet.Although a break in the wire could be confirmed from the returned images, the root cause of the damage could not be determined.This complaint will be recorded for future trending and monitoring purposes.
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 broken stylet is confirmed and was determined to be use-related.One fragment of a tls stylet was returned for evaluation.An initial visual observation of the returned stylet fragment showed blood residues throughout the device.The stylet fragment had one significant kink along the device, and a secondary kink nearby which included a broken magnet within the kink.The break site of the polyimide tubing, and blue shrink wrap, were sharply formed edges and appeared to coincide with a break in one of the magnets.The type of damage seen on that tubing is most consistent with sharp kinking of the stylet tip, which potentially caused breakage of magnets, which could have resulted in breakage of the tubing.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BARD PICC
• 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: jomil padin ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22178163
• Report Number: 3006260740-2025-03742
• Device Sequence Number: 12972282
• Product Code: LJS
• UDI-Device Identifier: 00801741034527
• UDI-Public: (01)00801741034527(11)230114(17)240331(10)REGZ1393
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2025

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 08/05/2025; 09/02/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/11/2025; 08/12/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2023
• 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: Required Intervention
• Patient Age: 15 MO
• Patient Sex: Unknown