MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	B91260490
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned for evaluation; however, it has not yet been received.Additional contact: (b)(4).
Event or Problem Description
The incident involved a 100" (254 cm) appx 12.8 ml, 15 drop primary set w/3 microclave®, rotating luer, filter cap on an unknown date.As per report, a syringe pump tubing was connected to the proximal site with propofol during infusion.At the same time, the anesthesiologist injected the propofol bolus at the 2nd site during induction.The propofol immediately moved up to the solute so, they had to clamp the tubing to ensure that the medication was directed to the patient.Once the patient was induced, they injected the antibiotic via the distal site and the same problem occurred (i.E.A return to the solute).The primary solute was connected to a 20g gauge peripheral permeable channel.It should be noted that the problem was not repeated with subsequent injections.The continuous infusion of propofol did not flow back to the solute at any time either.There was patient involvement and no adverse event reported.
Event or Problem Description
Update received where the customer reported that the involved product was a rimary set, 3 clave y-sites, 100 inch, non-dehp with list number: b91260490 and with lot number: 13539745.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.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 cause cannot be determined.The device history report (dhr) for lot: 13539745 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia 22790 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18105754
• Report Number: 9617594-2023-00963
• Device Sequence Number: 6004275
• Product Code: FPA
• UDI-Device Identifier: 00887709013025
• UDI-Public: (01)00887709013025(17)260301(10)13539745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 03/01/2026
• Device Catalogue Number: B91260490
• Device Lot Number: 13539745
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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.; UNSPECIFIED ANTIBIOTIC, MFR UNK.; UNSPECIFIED SYRINGE PUMP TUBING, MFR UNK.
• Patient Sex: Unknown