MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 C; STOPCOCK, I.V. SET

Catalog Number	A1145
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 12" smallbore hexafuse ext set w/6 microclave® clear, nanoclave® (red ring), 6 check valves, 7 clamps (green, 2 yellow, blue, light green, 2 white) luer lock.It was reported the precedex became disconnected from extension set and was undetected.Patient started having symptoms after not receiving the continuous medication.Bolus of versed was given to minimize withdrawal symptoms until a new bag was received.I'm not sure how much tighter the connections can be but somehow, they are able to come loose without even moving the patient.Missing microclave on end of tubing.The microclave missing from end of set- likely a lack of bonding.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where the male luer on the end of the set from the item #ac1145 is missing.No additional damage or anomalies were confirmed.One (1) used sample #a1145 was returned for evaluation.As received the male luer was observed to be missing from the device.The tube was analyzed through uv light and it was confirmed an insufficient solvent on tube.The missing male lues was not returned for evaluation.The tube was measured and it was found to be within specification.Complaint of separation can be confirmed based on the used physical sample evaluation and the photo shared by customer.The probable cause was due to insufficient solvent applied during manual process.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 C
• 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: 18325760
• Report Number: 9617594-2023-01155
• Device Sequence Number: 15212392
• Product Code: FMG
• UDI-Device Identifier: 00887709070103
• UDI-Public: (01)00887709070103(17)280201(10)13551568
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: A1145
• Device Lot Number: 13551568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: PRECEDEX, MFR UNK
• Patient Age: 18 MO
• Patient Sex: Male