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	Hypoglycemia (1912)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that the nurse was checking patient's glucose via bedside glucometer.Glucose read 12 when prior glucose obtained at 1530 was 67.Rn double checked the d30 fluid was running on the iv pump, then checked that the patient's continuous feed of 3mls was running and appropriately connected.Rn then double checked that the picc was patent and upon investigating, the picc dressing was completely occlusive with no border lifting but the piece of the catheter just past the wings of the external portion of the picc was completely snapped and separated from the rest of the catheter still connected to the patient.Nurse immediately called the apn to the bedside who held the picc remaining in the patient's arm so it did not migrate until a plan was formed.No patient harm reported.
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.

• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50778999
• Report Number: 3007697249-2026-00112
• Device Sequence Number: 21502740
• Product Code: LJS
• UDI-Device Identifier: 00858778006072
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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: 250708
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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 Sex: Unknown