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	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary set, 3 clave y-sites, 100 inch, non-dehp.It was reported a syringe pump tubing was connected to the proximal site, with propofol being infusion.Propofol immediately moved up to the solute.The tubing was clamped to make sure the medication went to the patient.Once the patient was induced, 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 peripheral permeable 20 g channel.He added that the problem was not repeated with subsequent injections and the continuous infusion of propofol did not flow back to the solute.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
Two (2) videos were returned for inspection.In the first video, the syringe was attached to the y-clave just distal of the back check valve (bcv) and in the second video the syringe was attached to the most distal y-clave site.In both videos, backflow was observed past the bcv and into the drip chamber.Received one (1) used and ten (10) new b91260490 primary sets for inspection.No damages or anomalies noted.To replicate clinical use, an icu medical provided 20 gauge needle was attached to the distal end of each set to replicate back pressure from a patient.Backflow was tested on each sample by infusing with an icu medical provided 20 ml syringe at the y-clave just distal of the bcv and the most distal y-clave.The roller clamp was adjusted to have both free flow and a drip rate of approximately 15 drops per minute for each infusion.There was no backflow observed on any of the returned sets.The reported complaint of backflow can be confirmed from the two (2) videos returned by the customer.However, the reported complaint could not be replicated with the returned one (1) used and ten (10) new b91260490 primary sets.The probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed 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 ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18140055
• Report Number: 9615050-2023-00637
• Device Sequence Number: 15449139
• Product Code: FPA
• UDI-Device Identifier: 10887787009306
• UDI-Public: (01)10887787009306(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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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 Expiration Date: 03/01/2026
• Device Catalogue Number: B91260490
• Device Lot Number: 13539745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, MFR UNK; UNSPECIFIED ANTIBIOTIC, MFR UNK
• Patient Sex: Unknown