MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET¿ RESERVOIR W/ SS PORT; CATHETER, CONTINUOUS FLUSH

Catalog Number	460560464
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident involved a safeset¿ reservoir w/ ss port.The report stated that the customer primed and attached an icumedical "safeset reservoir w/ss port" to patient's arterial line, then noticed saline leaking from the tubing area around the sampling port.Customer disconnected the safeset from the patient and primed/attached a new one.It appears there was no direct patient harm since the error was caught.There was patient involvement, however, there was no adverse event or harm as as a result of the reported event and no delay in therapy.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
The reported complaint of leak was confirmed on the returned set.No visual anomalies were observed.When primed and pressure leak tested, a channel leak was observed between the 52" pressure tubing and the safeset port.When the bond site was examined, insufficient solvent coverage was observed on the tubing pocket.The probable cause of the channel leak had occurred due to insufficient solvent coverage applied on the tubing during assembly at ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: SAFESET¿ RESERVOIR W/ SS PORT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 18104259
• Report Number: 9617594-2023-00962
• Device Sequence Number: 12151686
• Product Code: KRA
• UDI-Device Identifier: 00840619068950
• UDI-Public: (01)00840619068950(17)260201(10)13558251
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K932188
• 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): 11/20/2023

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: 02/01/2026
• Device Catalogue Number: 460560464
• Device Lot Number: 13558251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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: UNSPECIFIED ARTERIAL LINE, MFR UNK
• Patient Sex: Unknown