MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC.; INTRODUCER, CATHETER

Model Number	SHEATH1.4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse practitioner inserted central 1.4 fr, 26 gauge polyurethane footprint picc line into left arm of infant patient at 1 week of life, 28 and 1/7 weeks gestation for longer term tpn/intralipid therapy as his feedings are re-started and slowly advanced.Picc line was inserted into infant's left arm basilic vein without incident.Upon withdrawal of introducer needle, np then went to remove the introducer needle sheath.Upon attempt to remove sheath, only one half of the end of the breakaway sheath came off instead of both ends and the entire sheath peeling off.Attempt was made to remove the remainder of the sheath covering the catheter itself without success.Physician was consulted and decision made to remove the very end of the other half of the breakaway sheath and leave the 2 cm sheath over the very end of the line near the hub.Picc line is central in location and functioning well with good blood return and ability to easily flush catheter.2 days later, another np was able to carefully remove the sheath over the catheter without incident.Line remains intact and continues to function well.

• Brand Name: NA
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 12727 cimarron path; san antonio TX 78249
• MDR Report Key: 9659302
• Report Number: 9659302
• Device Sequence Number: 353856
• Product Code: DYB
• UDI-Device Identifier: 00858778006003
• UDI-Public: (01)00858778006003
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019
• Report Date (Section F): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SHEATH1.4
• Device Lot Number: 190481
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Weight: 2
• Date Report Sent to FDA: 12/19/2019