MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9438
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned; however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a 8" smallbore ext set w/clave®, clamp, rotating luer where it was reported a patient was having laryngospasm.Iv inserted with no issue.Drugs were given directly in the catheter to treat the laryngospasm before the iv line was connected.When the iv line was connected, it was difficult to connect to t-connector to catheter.When catheter was connected, the line was leaking.Issue was resolved once the t-connector was changed.When defective t-connector was inspected, a large crack was found in the slip tip portion of the connector along with an extra piece of plastic bent inside the connector.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
Received a photo from the customer showing the affected sample.Blood was visible in the female luer, however, no cracks or leaks were visible on the photo.The reported complaint of a leak and a crack could not be confirmed.Without the return of the sample, a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10 and e1.

• Brand Name: 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER
• 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: 21858046
• Report Number: 9617594-2025-00785
• Device Sequence Number: 15449103
• Product Code: FMG
• UDI-Device Identifier: 00887709013889
• UDI-Public: (01)00887709013889(17)291101(10)14215300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: B9438
• Device Lot Number: 14215300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: INTRAVENOUS LINE, UNK MFR.; INTRAVENOUS LINE, UNK MFR.; UNSPECIFIED CATHETER, MFR UNK.; UNSPECIFIED MEDICATION, UNK MFR.; UNSPECIFIED MEDICATION, UNK MFR.
• Patient Sex: Unknown