MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 42" (107CM) APPX 1.5 ML, SMALLBORE EXT SET W/T-CONNECTOR, PRE-SLIT PORT, CLAMP,; STOPCOCK, I.V. SET

Catalog Number	B1907
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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
It was reported that a 42" (107cm) appx 1.5 ml, smallbore ext set w/t-connector, pre-slit port, clamp, rotating luer generated a leak during patient infusion of adenosine.It was stated in the report that the product was leaking out of the connector when infused.There was no patient harmed but it resulted in a decreased dosage to the patient.It caused a radioactive spill and contamination to the staff and room and did not cause a delay in therapy.
Event or Problem Description
This report captures 3 occurrences.
Additional Manufacturer Narrative
Received five used.And thirty-three (33) new.Confirmed leaks on the 5 used, also found 9 of 33 new that were leaking.Customer included two photos for evaluation.No physical damage or other anomalies observed.Confirmed customer complaint of "leaking out of the connector when infused", probable cause, not fully inserted during assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.With the information provided it could not be determined which device returned related to which occurrence.Additional information in b5.

• Brand Name: 42" (107CM) APPX 1.5 ML, SMALLBORE EXT SET W/T-CONNECTOR, PRE-SLIT PORT, CLAMP,
• 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: 19591183
• Report Number: 9617594-2024-00809
• Device Sequence Number: 7195408
• Product Code: FMG
• UDI-Device Identifier: 00887709002630
• UDI-Public: (01)00887709002630(17)280401(10)13623827
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/22/2024

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: B1907
• Device Lot Number: 13623827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 06/22/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADENOSINE, UNK MFR
• Patient Sex: Unknown