MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 C; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3554
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a 22" (56 cm) add-on 150 ml burette set (microclave®, no shut-off), w/spiros®, 2 clamps, vented cap where it was reported that the burette was leaking from the bottom.The status of the product at the time of event was normal.There was patient involvement and no patient harm.This is the second of two events.
Additional Manufacturer Narrative
Received one used partial.List #ch3554, 22" (56 cm) add-on 150 ml burette set (microclave®, no shut-off), w/spiros®, 2 clamps, vented cap; lot #13657290.The base was not returned.The complaint of leakage and separation can be confirmed on the returned device.As received the base of the burette was separated.The bonding location on each burette was examined.Insufficient solvent coverage observed.The probable cause of the separation and leakage is due to insufficient solvent being applied during manual supplier's process assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 22" (56 CM) ADD-ON 150 ML BURETTE SET (MICROCLAVE®, NO SHUT-OFF), W/SPIROS®, 2 C
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17720447
• Report Number: 9617594-2023-00679
• Device Sequence Number: 17910637
• Product Code: FPA
• UDI-Device Identifier: 00887709076013
• UDI-Public: (01)00887709076013(17)280501(10)13657290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• 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): 11/16/2023

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: CH3554
• Device Lot Number: 13657290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2023
• 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
• Patient Sex: Unknown