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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
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 that during an infusion, leaking was noted near nanoclave on leg with white and yellow clamps.It appears that this may be due to issue with bonding.The open fluid pathway increases risks for catheter associated blood stream infection.There was patient involvement however, no harm was reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
A couple of photos were shared by customer, where a leaks coming from the set #1145 its observed.It's not clear if the leak is coming from the white or yellow clamp connection.One (1) used sample item #a1145 was returned for evaluation.As received no physical damage or anomalies were observed in the sample.No mating device was returned.The set was tested as per procedure and leaks coming from the check valve and male luer bond.No another leaks along the device were observed.Complaint of leaks can be confirmed.The probable cause was due to an incomplete insertion during manufacturing process assembly.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: 17912199
• Report Number: 9617594-2023-00821
• Device Sequence Number: 15334908
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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: INTRALIPIDS, MFR UNK.
• Patient Age: 11 DA
• Patient Sex: Female