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
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 an 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 generated a no-flow event during use.It was reported that the nurses and anesthesiologist reported that on week (b)(6) 2024, the needless port valve doesn't open up when the medline is screwed in.Therefore, the med will not infuse.It has happened several times now with this batch.They ordered 4 cases and have only opened 1 box so far.The anesthesiologist doesn't want to use the same brand.The event occurred during active patient use (device actively connected to the patient).The medications involved were propofol and remifentanil.The returning samples are new; the used ones were disposed of.The sample is available for return.There was no injury/death.
Additional Manufacturer Narrative
Five (5) 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.Each of the sets was primed and no occlusion or flow restriction during priming was confirmed.The complaint that the needless port valve doesn't open up cannot be confirmed or replicated.The device history review (dhr) lot#8031785 was reviewed and no non-conformities were found that would have led to the reported condition on the complaint.D9 - date returned to mfg: 7/8/2024.

• 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: 19540771
• Report Number: 9617594-2024-00767
• Device Sequence Number: 7606302
• Product Code: FMG
• UDI-Device Identifier: 00887709079502
• UDI-Public: (01)00887709079502(17)270801(10)8031785
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: 8031785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• 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: PROPOFOL, UNK MFR; REMIFENTANIL, UNK MFR
• Patient Sex: Unknown