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	07/20/2024
Type of Reportable Event	Serious Injury
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.
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 generated a leak during patient use.It was stated in the report that the patient had a line change during the day shift.They completed the complete line change.All tubing was primed and capped correctly on the manifold with the "tail".They disconnected and did a cap change on all lumens and connected the new lines/tubing to the new caps.The patient started decompensating ~5 hours after the line change, and the withdrawal assessment tool score (wats) was a 6.They tried to figure out the problem, and when giving as-needed medications (prns) at the central venous pressure (cvp)/push port, they noticed the lines were wet.They traced the lines and found the manifold to be defective and leaking at the site where the "tail" and manifold come together.They immediately disconnected the defective manifold and primed a new manifold to attach drops (gtts).After prns were given and a new manifold was attached to the patient, the patient calmed down and vitals stabilized.There was no patient harm reported.
Additional Manufacturer Narrative
Corrected information can be found in b1 and h1.Additional information can be found in b2 and b5.One used list# am6109, 10", connected to an used, blue connector and an unknown, clave was returned for evaluation.As received an incomplete fully insertion between the adaptor and the manifold was observed, additional a leaking from a crack located on the adapter was observed.The returned set was tested as procedure and a leak from the crack on the adaptor and between manifold was observed.It was observed the female luer was spinning freely connected into the manifold, meaning an incomplete insertion.Complaint of leaks can be confirmed.The probable cause was due an incomplete insertion between adaptor and manifold during manufacturing process.The probable cause of the crack observed on the female luer adaptor is unknown.
Event or Problem Description
New information was received stating that the medication not reached the patient leading to deteriorating vital signs, increased agitation.Patient recovered after broken manifold replaced.The delay in therapy occurred after cap change.There was patient harm.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20571387
• Report Number: 9617594-2024-01538
• Device Sequence Number: 15454464
• 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): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/08/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID, UNK MFR.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown