MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3" (8 CM) APPX 0.22 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 2 CLAMPS (BLUE; STOPCOCK, I.V. SET

Catalog Number	B33868
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received 3 samples all were used list #b33868, 3" (8 cm) appx 0.22 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps (blue), rotating luer; lot #unknown.--> one (1) used.List #unknown, spiros no physical damage or other anomalies observed.Each set was leak tested; all 3 sets passed.Could not confirm complaint of cracking between the blue cap and plastic clear line.D9 - date returned to mfg: 31jul204.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a 3" (8 cm) smallbore bifuse ext set w/2 microclave¿, 2 clamps (blue), rotating luer where it was reported that reoccurring issue of b33868 cracking between the blue cap and plastic clear line.No further details were provided.

• Brand Name: 3" (8 CM) APPX 0.22 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE®, 2 CLAMPS (BLUE
• 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: 19997521
• Report Number: 9617594-2024-01148
• Device Sequence Number: 15268413
• Product Code: FMG
• UDI-Device Identifier: 00887709084223
• UDI-Public: 00887709084223
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: B33868
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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