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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 10" (25 cm) smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer was found to leak during patient use.It was stated in the report that they found a wet spot on the bed under the manifold of the patient, medications going into the manifold included epi for bp management and dex for sedation.Found to have a leak/crack in manifold-tail connection all one piece in the package.There was no patient harm reported.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
Received one new list# am6109, 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer.As received, no physical damage or other anomalies observed.Leak tested per manufacture procedure; no leaks observed.Cannot confirm customer complaint of "found to have leak/crack in manifold-tail connection all one piece in package".A device history lot and relevant commodities were reviewed, the following discrepancy was identified: exception type: ncmr lot#: 9551917 discrepancies: during functional quality control sampling in assembly operation 40, 2 pieces with leaks at 45 psi are detected, in order (b)(6).Item x1-5020.When? on september 27, 2022, second shift.Where? in the assembly area, manifold line, cr1b.Quantity impacted and sampling results (fail/pass): in the first sampling, one piece out of 6 inspected was rejected and in a subsequent sampling, 1 more piece out of 12 inspected was rejected.2400 pieces are left detained.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20578454
• Report Number: 9617594-2024-01541
• Device Sequence Number: 15615751
• Product Code: FMG
• UDI-Device Identifier: 00887709077645
• UDI-Public: 00887709077645
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/09/2024

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: AM6109
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown