MAUDE Adverse Event Report: Footprint Medical Inc. PICCs, Footprint, Polyurethane; Peripherally Inserted Central Catheter (PICC)

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch that fractured picc fragment seen at the svc.Xray finding revealed there is a picc which projects at the superior vena cava.Picc is discontinuous, with a defect seen at the subclavian.28 week, 2 day gestation premature, twin neonate at the time of birth.Neonate had a picc line placed to the left extremity.
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.This event was previously reported to fda in medwatch report 3006260740-2026-06125 on august 25, 2026, with a manufacturer awareness date of august 04,2026.The original medwatch report was submitted under an incorrect site legal name and site registration number.This medwatch report is being submitted under the correct site legal name and site registration number and represents a duplicate report of the same event for administrative correction purposes only.The manufacturer awareness date in this report reflects the date the reporting error was identified.The original manufacturer awareness date remains august 04, 2026.No new or additional event, patient, or device information is being reported.

• Brand Name: PICCs, Footprint, Polyurethane
• Common Device Name: Peripherally Inserted Central Catheter (PICC)
• Manufacturer (Section D): Footprint Medical Inc.; 5823 sebastian place; san antonio TX 78249
• Manufacturer (Section G): Footprint Medical Inc.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: becky sparks ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50674241
• Report Number: 3007697249-2026-00102
• Device Sequence Number: 16058133
• Product Code: LJS
• UDI-Device Identifier: 00858778006072
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: P1PIC14S
• Device Lot Number: 260083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• 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: 1 MO
• Patient Sex: Male
• Patient Weight: 4 LB
• Patient Race: White