MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	AM6109
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
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 incident involved a 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer.It was reported that there was leaking found in the patient's bed.The leak location is unknown.The event occurred in neonatal intensive care unit (nicu).The reporter became aware of the issue when they noticed that patient's sheet was wet.The medication involved is unknown.The product was not reprocessed or re-sterilized prior to use.There was patient involvement, no harm/adverse event, and no delay in therapy.
Additional Manufacturer Narrative
One (1) used sample list #am6109 was returned for evaluation.As received some marks inside the check valve's thread and manifold were observed, however they did not compromise the set functionality.No damage, cracks or additional anomalies were observed.The set was tested according procedure and no leaks, occlusion or anomalies along the device were observed.Complaint of leaks was not able to confirmed or replicated.A device history review (dhr) was performed and no relevant commodities, discrepancy or anomalies were found that might be related with the condition reported by customer.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING
• 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: 17585254
• Report Number: 9617594-2023-00564
• Device Sequence Number: 14672593
• Product Code: FMG
• UDI-Device Identifier: 00887709077645
• UDI-Public: (01)00887709077645(17)271001(10)11001834
• 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: AM6109
• Device Lot Number: 11001834
• 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: 09/01/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: PUMP TUBING, B. BRAUN.
• Patient Sex: Unknown