MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	AM3090
Medical Device Problem Codes	Break (1069); Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event occurred on an unspecified date and involved a 10" ext set w/3-port nanoclave® manifold, check valve, clamp, luer lock.The customer reported that they had an issue wherein a port on the manifonifold was broken and caused medication (vasporessors) to not be delivered as intended to the patient; the patient's blood pressure dropped (systolic in the 70s and mean arterial pressure was in the 40s).There was a delay in therapy as the vasopressor medications were running through this port and were not reaching patient since they were leaking out of the broken seam.The intervention was rearranging the infusion to a different delivery system.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One (1) used sample # am3090 was returned for evaluation.As received one of the nano manifold clave was observed to be broken off from manifold base.The missing nano manifold clave was not returned for evaluation.It was confirmed from the broken nanoclave an insufficient adhesive applied.The 2 nanoclave left were torque tested and they met product specification.The complaint of leaks can be confirmed based on the used physical sample evaluation.The probable cause was due to insufficient adhesive applied during manual process assembly during manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK
• 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: 18412798
• Report Number: 9617594-2023-01204
• Device Sequence Number: 11431279
• Product Code: FMG
• UDI-Device Identifier: 00887709080799
• UDI-Public: (01)00887709080799(17)280501(10)13635217
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/11/2024

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: AM3090
• Device Lot Number: 13635217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: VASOPRESSOR MEDICATION, MFR UNK.
• Patient Sex: Unknown