MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 21" (53 CM) APPX 5.4 ML, TRANSFER SET W/8 CLAVE¿, 4 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET

Catalog Number	B33974
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 21" (53 cm) appx 5.4 ml, transfer set w/8 clave¿, 4 tri-connectors, back check valve, clamp (blue), vented cap where it was reproted the 8-port manifold was infusing mycophenylate when another manifold port with used tubing for ganciclovir disconnected below needleless connector.This caused hazardous medication spill of mycophenylate ~100 ml.Spill cleaned with spill kit and surface safe per policy.They did not sequester per material services request as infusing hazardous meds, thus no sample is returning for testing.There was patient involvement and unknown human harm however no other details were provided.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Possible lot numbers: 13833492 manufactured date 12/2023.1386766 manufactured date 01/2024.
Additional Manufacturer Narrative
A photo was returned showing the clave missing from the bond pocket of the tri-connector.The reported complaint of separation can be confirmed on the b33973 transfer set w/4 clave.The probable cause is due to a manual bonding error.
Event or Problem Description
Additional information provided on 20may2024 via medwatch (b)(4) there was also precipitation observed down the iv tubing, which was caught before it reached patient.It is unclear whether this was due to the manifold defect however, mycophenolate and ganciclovir are not compatible.
Additional Manufacturer Narrative
Correction: related report number added to h10 versus in b5 from previous supplemental report.

• Brand Name: 21" (53 CM) APPX 5.4 ML, TRANSFER SET W/8 CLAVE¿, 4 TRI-CONNECTORS, BACK CHECK V
• 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: 19029821
• Report Number: 9617594-2024-00359
• Device Sequence Number: 15483960
• Product Code: FMG
• UDI-Device Identifier: 00887709123991
• UDI-Public: (01)00887709123991
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2024

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: B33974
• Device Lot Number: PLOTS
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 06/06/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/28/2024; 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: GANCICLOVIR; MYCOPHENYLATE, MFR UNK
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 89 KG