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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 329167859
• Report Number: 9617594-2023-01041
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709121379
• UDI-Public: (01)00887709121379(17)271101(10)12161447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FENTANYL, MFR UNK; LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK