MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. MICR0BORE EXT SET 5IN PP T-SITE NDEHP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	114020428
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a micr0bore ext set 5in pp t-site ndehp where the customer stated that a patient was in bed when a caregiver went into the room, she thought that the patient had completely pulled the peripherally inserted central catheter (picc) line.The nurse was notified and upon inspection, the picc was still in place, but the t-connector had come apart where the tubing attaches to the green hub.The nurse practitioner was able to save the picc but new tubing was needed.The open area, where the tubing disconnected, exposed the infant to potential infection.This is the second one they have done this but do not have lot numbers.The patient was female, black, or african american.The event occurred in the hospital in neonatal intensive care unit (nicu).The original intended procedure was connector for peripherally inserted central catheter and tubing.There was patient involvement and unknown patient or staff harm.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.
Additional Manufacturer Narrative
D9 - date returned to mfg - 27 jun 2024.Investigation summary: received one (1) used 114020428 micr0bore ext set 5in pp t-site ndehp for inspection.The t-connector was observed to be separated from the tubing.Evaluation of the bond area showed little to no solvent.The tubing was measured and found to meet dimensional requirements.The needless access device could not be removed from the device.Crazing was observed on the female luer.The probable cause of the crazing and unable to remove the mating device is due to environmental stress during use.Lot history review could not be reviewed due to the unknown lot number.The reported complaint of a separation can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly in costa rica.

• Brand Name: MICR0BORE EXT SET 5IN PP T-SITE NDEHP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19536149
• Report Number: 9615050-2024-00467
• Device Sequence Number: 17684948
• Product Code: FPA
• UDI-Device Identifier: 10887787005124
• UDI-Public: (01)10887787005124
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142974
• 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,Followup
• Report Date (Section B): 02/04/2025

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 Catalogue Number: 114020428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 08/05/2023
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic