MAUDE Adverse Event Report: Footprint Medical Inc. 1.4 French Peel-away Sheath Introducer; PICC Accessories

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when you peel the banana, one side doesn't peel off all the way and gets stuck on the catheter.This time it broke off on the bottom.No further 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.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.This event was previously reported to fda in medwatch report 3006260740-2026-06411 on september 2, 2026, with a manufacturer awareness date of august 17,2026.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 17, 2026.No new or additional event, patient, or device information is being reported.

• Brand Name: 1.4 French Peel-away Sheath Introducer
• Common Device Name: PICC Accessories
• 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: 50775484
• Report Number: 3007697249-2026-00109
• Device Sequence Number: 10416428
• Product Code: DYB
• UDI-Device Identifier: 00858778006003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SHEATH14
• Device Lot Number: 2602720
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown