MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 84" (213 CM) 60 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/Y SITE, 2 MICROCLAVE; STOPCOCK, I.V. SET

Catalog Number	MRSA60-84
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device has been disposed; however, new samples are available for evaluation.The device has not yet been received.Additional reporter: (b)(6).
Event or Problem Description
The event involved a 84" (213 cm) 60 drop, vented/non-vented gravity admin set w/y site, 2 microclave® clear, rotating luer, approx priming volume: 10.8 ml where it was reported by the nurses and anesthesiologist that the needless port valve doesn't open up when the medline is screwed in, and medication will not infuse.Medications involved were propofol and remifentanil.The event occurred during active patient use (device actively connected to the patient).There was patient involvement, however, no report of patient harm.
Additional Manufacturer Narrative
Forty-four (44) new.List #mrsa60-84, 84" were returned for evaluation.As received no anomalies, damage or anomalies were observed.No mating device was returned for evaluation.The 35 samples were taken based on the binomial stages sampling to represent the lot population and each of the them was primed and no occlusion or flow restriction during priming was confirmed.Complaint of needless port valve doesn't open up cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 84" (213 CM) 60 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/Y SITE, 2 MICROCLAVE
• 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: 19535667
• Report Number: 9617594-2024-00762
• Device Sequence Number: 20895918
• Product Code: FMG
• UDI-Device Identifier: 00887709079502
• UDI-Public: (01)00887709079502(17)280701(10)13716043
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: MRSA60-84
• Device Lot Number: 13716043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: PROPOFOL, UNK MFR; REMIFENTANIL, UNK MFR
• Patient Sex: Unknown