MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, Y; STOPCOCK, I.V. SET

Catalog Number	AM6100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
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 event involved a 10" smallbore ext set w/6-port nanoclave® manifold (orange, red, blue, purple, yellow rings), check valve, clamp, rotating luer.It was stated in the report that the product is leaking at the rotating luer connection on smallbore tubing.The event occurred on (b)(6) 2023 at 5:30 am during use on a patient, but unknown how long it was in use.Additionally, the product is available for evaluation and a medication was being used with this product.There was patient involvement, no harm or adverse event reported and no delay in therapy.Total parenteral nutrition, morphine, dexmedetomidine, and versed were infusing at the time the leak was found.There was no obvious defect or crack noted.
Additional Manufacturer Narrative
One (1) used.List #am6100, 10" smallbore ext set w/6-port nanoclave® manifold (orange, red, blue, purple, yellow rings), check valve, clamp, rotating luer; lot #1354288 was returned for the investigation.Leakage at the bond between the female luer to male luer at the distal end of the assembly was confirmed.The probable cause is incomplete bond connection between the male and female luers at the distal end of the am6100 during bonding assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint additional information, the product was returned 8/29/2023.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD (ORANGE, RED, BLUE, PURPLE, Y
• 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: 17728130
• Report Number: 9617594-2023-00687
• Device Sequence Number: 6164180
• Product Code: FMG
• UDI-Device Identifier: 00887709070660
• UDI-Public: (01)00887709070660(17)280201(10)13542886
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/18/2023

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: AM6100
• Device Lot Number: 13542886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: DEXMEDETOMIDINE, MFR UNK; MORPHINE, MFR UNK; TOTAL PARENTERAL NUTRITION, MFR UNK; VERSED, MFR UNK
• Patient Sex: Unknown