MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1016
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved an 8" (20 cm) ext set w/1.2 micron filter, clamp, rotating luer where it was reported several devices being broken creating interruption in patient care and needed therapy.Mostly events were reported from pediatric intensive care unit (picu).It was stated that the tubing is separating where it is attached to the blue filter.The piece is a permanent attachment to the filter itself.The filter was connected to the intravenous (iv) tubing and attached to the patient.The patient involved was a neutropenic patient and the event resulted in a large amount of blood in the bed, however, the volume wasn't large enough to require transfusion.There was patient involvement, however, no report of harm.
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.If the device is returned a supplemental report will be submitted.
Additional Manufacturer Narrative
Received four hundred and twenty new b1016 ext set w/1.2 micron filter for inspection.No defects or anomalies noted.A bond integrity test was according to product specifications.Each sample met performance expectations.Although the separation could not be replicated on the new sets during testing, the reported complaint of separation can be confirmed based on a lot history review.The probable cause is due to insufficient solvent applied during manual assembly.The lot history was reviewed, and corrective actions are in process.Updated information in d9.D9 device returned to manufacturer on 7/15/2024.

• Brand Name: 8" (20 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; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19536553
• Report Number: 9617594-2024-00764
• Device Sequence Number: 15006708
• Product Code: FMG
• UDI-Device Identifier: 00887709000087
• UDI-Public: (01)00887709000087(17)281201(10)13847714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/09/2024

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: B1016
• Device Lot Number: 13847714
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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
• Patient Sex: Unknown