MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NEUTRON®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-NC100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Photos were provided by the customer.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on an unspecified date in may 2025 and involved a neutron®.It was stated that the cancer services at gosford have reported a quality issue with the neutron needless connector.The valve has snapped off inside the peripherally inserted central catheter (picc) lumen, and the picc needed to be replaced.The issue was noted during use on patient.There was patient involvement and delay in therapy, but no one was harmed in the reported event.
Additional Manufacturer Narrative
Correction: supplemental mdr 9617594-2025-01252-01, was sent with the incorrect investigation due to report workflow error.The correct investigation is below.Corrections: h6, g, b, c, and d codes updated.H10 - no related record.Please disregard the enter related report on previous supplemental mdr.Investigation summary: a couple of photos were shared by customer, where a broken piece of neutron's male luer is observed to be stuck, and another neutron is connected on the other side of the set, no additional damage or anomalies were observed.The complaint of separation can be confirmed.Since no product sample was received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record review couldn't be performed due to the lot number for this complaint was unknown.
Additional Manufacturer Narrative
One (1) used.List #mc330583, 102" (259 cm) appx 5.0 ml, transfer set w/microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear, 0.2 micron filter, clamp, rotating luer; lot #14271059.Two (2) used.List #unknown, extension tubing with clave; lot #unknown.One (1) used.List #unknown, edwards transducer; lot #unknown.One (1) used.List #unknown, microclave; lot #unknown.One (1) used.List #unknown, stopcock; lot #unknown.One (1) used.List #unknown, microclave; lot #unknown.One (1) used.Extension tubing with microclave and filter; lot #unknown.One (1) used.List #unknown, bifuse device; lot #unknown.Two (2) used.List #unknown, microclave; lot #unknown.Two (2) used.List #unknown, extension tubing with microclave; lot #unknown.One (1) used.List #mc330583, 102" (259 cm) appx 5.0 ml, transfer set w/microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear, 0.2 micron filter, clamp, rotating luer; lot #14271059.One (1) used.List #unknown, extension tubing with microclave and filter; lot #unknown.One (1) used.List #unknown, bifuse device; lot #unknown.Two (2) used.List #unknown, microclaves; lot #unknown.Two (2) used.List #unknown, extension tubing with microclaves; lot #unknown.No visual damages or anomalies were observed on any sample.The reported complaint of a leak could be confirmed.The returned samples were tested an a leak was observed on the inline filter.The probable cause of the leak is from the temporary loss of hydrophobic properties.The device history record lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: NEUTRON®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22203429
• Report Number: 9617594-2025-01252
• Device Sequence Number: 6746591
• Product Code: FPA
• UDI-Device Identifier: 00840619054076
• UDI-Public: (01)00840619054076
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100434
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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: 011-NC100
• Device Lot Number: UNKNOWN
• 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: 05/18/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 06/13/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/11/2025; 07/11/2025
• 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: PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR
• Patient Sex: Unknown