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	07/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for investigation.Investigation is pending.
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, where it was reported that the nanoclave manifold leaked near the base of the 2 nanoclaves nearest to extension tubing.The customer discovered the wet area on the patient in cvicu during infusion.The medication involved is unknown.There was patient involvement, no harm/adverse event, and no delay in therapy.
Additional Manufacturer Narrative
The complaint of leakage can be confirmed on the returned one used.List #am6100, 10" smallbore ext set w/6-port nanoclave® manifold (orange, red, blue, purple, yellow rings), check valve, clamp, rotating luer; lot #13542886.As received there were residuals observed inside the threads of the distal male luer attached the female luer and tubing.The returned set was leak tested per product specification.There was a leaks observed at the distal bonded location of the male luer of the manifold to the female luer of the tubing.The female luer was not fully inserted into the male luer.The probable cause of the leak observed is due to an the female luer not being fully inserted during the manual assembly at the manufacturing site.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 17556990
• Report Number: 9617594-2023-00559
• Device Sequence Number: 14316312
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: AM6100
• Device Lot Number: 13542886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/04/2023
• 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: UNSPECIFIED MEDICATION, UNK MFR; UNSPECIFIED PUMP TUBING, BBRAUN
• Patient Sex: Unknown