MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1415
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 7" smallbore ext set w/clamp, rotating luer that reportedly detached from the iv (intravenous) line and leaked during a baby's infusion.The reporter stated that the baby was placed into hold at 1600h with his mother.The lines were clamped to his mom's gown, with plenty of slack.At 1800h, while preparing to move the baby back to bed, the clinician noticed wetness near the peripherally inserted central catheter (picc) site.It was further observed that the picc hub was open to air, and the extension set (between the picc and neutron) had fully detached from the line.No harm or adverse event was reported with respect to this complaint/event.
Additional Manufacturer Narrative
The reported complaint of air in line could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot number was provided for a device history record lot review.

• Brand Name: 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21575245
• Report Number: 9617594-2025-00447
• Device Sequence Number: 12869455
• Product Code: FMG
• UDI-Device Identifier: 00887709001565
• UDI-Public: 00887709001565
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: B1415
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED NEUTRON DEVICE, MFR ICU MEDICAL.; UNSPECIFIED PICC LINE, MFR UNK.
• Patient Sex: Unknown