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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a ext set, smallbore with clave where it was the silicone clave was sunken and leaked from clave.There was leakage at the drip chamber.The set was replaced and therapy resumed without any problem.The concomitant drug used was an antibiotic.The event occurred during infusion.Device was not reprocessed or re-sterilized.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
Received one used 011-c3302 ext set smallbore with clave.The seal on the clave was not stuck down as received.No defects or anomalies noted.No mating devices were returned for inspection.The set was leak tested per product specifications.There was no leakage.The clave was disassembled, and no defects or anomalies were found.The reported complaint was unable to be replicated or confirmed.A device history lot # review could not be conducted because no lot number(s) was/were identified.

• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20921706
• Report Number: 9617594-2024-01777
• Device Sequence Number: 8391027
• Product Code: FMG
• UDI-Device Identifier: 00840619001537
• UDI-Public: 00840619001537
• 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): 01/15/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 ANTIBIOTICS, UNK MFR
• Patient Sex: Unknown