MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1115
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer.The customer reported that the nurse noticed a soiled blanket and upon further investigation, the tubing connected to the actual filter was not intact (was disconnected).The customer stated that the issue was identified with supply item.The nursing department was affected by the issue.The customer stated that a midas incident report was created and assigned the midas case number (b)(4).There was unknown patient involvement, unknown human harm/adverse event, and unknown delay of therapy.
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
Additional information was received stating that here was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Additional information b3, b5 and d9.
Additional Manufacturer Narrative
One (1) used sample list #b1115, 12" was returned for evaluation.As returned the tube from the inlet filter port was observed to be separated from the filter.Both components were observed through ultraviolet (uv) light and no solvent marks were observed.The optical density (od) of the separated tube was measured finding it within specification.Complaints of separation can be confirmed based on the physical sample evaluation.The probable cause is due to an insufficient solvent applied during manual process assembly in ensenada.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.D9 - device available for evaluation: yes; d9 - date returned to mfg: 9/18/2024.

• Brand Name: 12" (30 CM) EXT SET W/1.2 MICRON FILTER, 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20000805
• Report Number: 9617594-2024-01160
• Device Sequence Number: 7414402
• Product Code: FMG
• UDI-Device Identifier: 00840619045524
• UDI-Public: 00840619045524
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/01/2024

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: B1115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 10/04/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/30/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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