MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.31 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS, LUE; STOPCOCK, I.V. SET

Catalog Number	B33099
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a a smallbore bifuse ext set w/2 microclave¿, 2 clamps, it was stated that the bifuse was leaking around the blue mircroclave during normal saline flush.There was no report of harm.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one (1) used b33099 smallbore bifuse extension set w/2 microclaves for inspection.No defects or anomalies noted.The set was leak tested per product specifications.There was no leakage.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: 6" (15 CM) APPX 0.31 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS, LUE
• 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; .
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19387734
• Report Number: 9617594-2024-00650
• Device Sequence Number: 6988919
• Product Code: FMG
• UDI-Device Identifier: 00887709006270
• UDI-Public: (01)00887709006270(17)281001(10)13791415
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: B33099
• Device Lot Number: 13791415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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
• Patient Sex: Unknown