MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 61" (155 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE¿, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B33711
Medical Device Problem Codes	Crack (1135); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The blue cap of a 61" (155 cm) appx 1.0 ml, smallbore ext set w/microclave¿, clamp, luer lock was reportedly cracked.The nurse started cefepime antibiotic using med tubing for an unspecified syringe pump, and upon attempting a saline flush (after antibiotic infused), the blue cap was observed to cracked and the inner piece was coming apart.There was no patient harm.
Additional Manufacturer Narrative
One used smallbore ext set w/microclave and one used microclave were returned for evaluation.The blue housing on the microclave of the smallbore ext set was separated from the internal spike.The blue housing had a crack.A small white discoloration spot was observed on the crack.The reported complaint of the crack and separation can be confirmed.The probable cause is due to a molding error.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 61" (155 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE¿, CLAMP, LUER LOCK
• 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: 23380678
• Report Number: 9617594-2025-02038
• Device Sequence Number: 15657327
• Product Code: FMG
• UDI-Device Identifier: 00887709077379
• UDI-Public: (01)00887709077379(17)291101(10)14231970
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/04/2025

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: B33711
• Device Lot Number: 14231970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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: CEFEPIME, MFR UNK; PRIMARY IV LINE, MFR UNK; SALINE, MFR UNK; UNSPECIFIED SYRINGE PUMP, MFR UNK
• Patient Sex: Unknown