MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV; STOPCOCK, I.V. SET

Catalog Number	AM3020
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 112" 15 drop primary set w/3 microclave¿, 3-port nanoclave¿ manifold, check valve, rotating luer where it was reported the valves in the manifold seem to malfunction (specifically the port proximal to the patient).It was stated that the part that is having an issue is the third port on the manifold, closest to the patient/end of the set.The clinicians prime the set, close the roller clamp at the top, and then attach the syringes to the manifold for when they are ready to administer the medication.The port on the manifold closest to the patient is pulling the medication from the attached syringe on its own and into the patient.This occurred after the lines were primed and hooked up to the patient but prior to the start of infusion causing the medication to be delivered prematurely to the patient without a clinician administering it.There was patient involved, however, no patient harm and no delay in therapy.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The complaint of defective/malfunctioning components on item am3020 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.The lot history #5759588 was reviewed and no nonconformities were found that would have led the reported condition on the complaint.Updated information in d9.

• Brand Name: 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV
• 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: 19143167
• Report Number: 9617594-2024-00464
• Device Sequence Number: 7959882
• Product Code: FMG
• UDI-Device Identifier: 00887709088511
• UDI-Public: (01)00887709088511(17)270101(10)5759588
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/30/2024

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: AM3020
• Device Lot Number: 5759588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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: UNSPECIFIED SYRINGE, UNK MFR.
• Patient Sex: Unknown