MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SP; STOPCOCK, I.V. SET

Catalog Number	AC315
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The incident involved a 12 in (30 cm) appx 1.6 ml, ext set w/3-gang nanoclave¿ stopcock w/nanoclave¿, spin luer on an unknown date.It was reported that the manifold was leaking between two of the stopcocks where it is supposed to be bonded.The manifold had been in place for 5 hours before the leaking was noticed.No hemostats were used on this device.It was confirmed that this was not spillage that occurred while the manifold was being set up.The event happened in neonatal intensive care unit (nicu).There was patient involvement and no human harm was reported to be associated with the event.
Additional Manufacturer Narrative
One photo was shared by the customer, where the item #ac315 is observed inside of a plastic bag, and the source of the leaking was noted.However, no leaks or anomalies were observed on the photo.One used sample #ac315 was returned for evaluation.As received, unknown medication residuals were observed inside the sample.No mating device was returned for evaluation.The set was tested as per procedure and a leak (between the stopcocks) was confirmed.Sufficient solvent was identified.The complaint of leaks can be confirmed based on the used physical sample evaluation.The probable cause is incomplete insertion during the manual process assembly of manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 12 IN (30 CM) APPX 1.6 ML, EXT SET W/3-GANG NANOCLAVE¿ STOPCOCK W/NANOCLAVE¿, SP
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18221852
• Report Number: 9617594-2023-01041
• Device Sequence Number: 5788321
• Product Code: FMG
• UDI-Device Identifier: 00887709121379
• UDI-Public: (01)00887709121379(17)271101(10)12161447
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: AC315
• Device Lot Number: 12161447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: FENTANYL, MFR UNK; LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Sex: Unknown