MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP LS 1.2FLT 15IN EXT-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1141505
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Additional contact information: (b)(6).
Event or Problem Description
The event occurred in a hospital patient room and involved a lifeshield¿ extension set - 15 inch 1.2 micron filter, prepierced y-site, non-dehp.A user facility mandatory medwatch (#(b)(4)) was received that stated, ¿the nurse went to discard the old tpn (total parenteral nutrition), tubing, and extension set to replace it with new tpn, tubing, and extension set.On an attempt to remove the extension set from the cvc lumen, the secure lock male adapter was unscrewed upon pulling back it would not dislodge from the cvc lumen.Multiple attempts were made to remove the line with no success.On the last attempt, the tip of the adaptor broke off in the purple lumen; discarding old tpn, tubing and extension set to replace with new was the original intended procedure.Devices failed was the problem of the user have.Other therapies used on the patient at the time of the event that may have caused or contributed to the event: total parenteral nutrition (tpn) becomes sticky when it dries.¿ it was later reported by the customer that the sticky tpn dried around the secure lock male adaptor of the extension tubing, making it difficult to remove from the cvc lumen.Although there was patient involvement, there was no adverse event or human harm.

• Brand Name: NDEHP LS 1.2FLT 15IN EXT-SL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15190530
• Report Number: 9615050-2022-00166
• Device Sequence Number: 5851370
• Product Code: FPA
• UDI-Device Identifier: 10887787005131
• UDI-Public: (01)10887787005131(17)241101(10)5634863
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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 Expiration Date: 11/01/2024
• Device Model Number: 1141505
• Device Catalogue Number: 114150451
• Device Lot Number: 5634863
• 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: 05/11/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CVC LUMEN, MFR UNK; TOTAL PARENTERAL NUTRITION, MFK UNK; UNSPECIFIED TUBING AND EXTENSION SET, MFR UNK
• Patient Sex: Unknown