MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, SMALLBORE WITH CLAVE¿; STOPCOCK, I.V. SET

Catalog Number	011-C3302
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a ext set, smallbore with clave¿.It was reported that the solution could not drip during a patient's infusion.There was no concomitant drug and no concomitant device involved.There was no bleed back or biohazard.There was no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional contact: (b)(6).Products dept.Specialist (b)(6).
Additional Manufacturer Narrative
The following was provided by the customer for investigation: -one used 011-c3302 extension set attached to one used list #unknown infusion set and one used list # unknown 500 ml sodium chloride bag.No defects or anomalies were noted.As received, the setup was hung from an iv pole and primed.There were no issues in priming.The 011-c3302 extension set was disconnected from the set and individually primed.The set primed at gravity pressure.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EXT SET, SMALLBORE WITH CLAVE¿
• 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: 19093684
• Report Number: 9617594-2024-00409
• Device Sequence Number: 15387752
• Product Code: FMG
• UDI-Device Identifier: 00840619001537
• UDI-Public: (01)00840619001537(17)280501(10)13655157
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 011-C3302
• Device Lot Number: 13655157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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 SOLUTION/INFUSATE, MFR UNK.
• Patient Sex: Unknown