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 Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, 01 jan 2024 has been used as placeholder.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer experienced breakage and leakage.The report states that ¿upon assessment, noted lipid filter broken.Tubing infusing directly to bed.Filter still attached to y-connector on cvc; backflow of blood noted in filter.Tpn still infusing on other port of y-connector.Both tpn and il infusions stopped immediately; tubing removed and discarded.Cap changed with picl and line heparin-locked.¿ there was patient involvement and unknown adverse event.Additionally, the initial reporter asked the customer if there were any patients were harmed/affected and the customer answered that "tpn had to be stopped and the lipids discarded".
Additional Manufacturer Narrative
Received one used b1115 ext set w/ 1.2 micron filter for inspection.The tubing was separated from the inlet port on the 1.2 micron filter.The bond area had little to no solvent present.The outlet bond was tested for bond integrity per product specifications.The representative bond met performance expectations.The reported complaint can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Updated information in d9.

• 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; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20641540
• Report Number: 9617594-2024-01577
• Device Sequence Number: 18007736
• Product Code: FMG
• UDI-Device Identifier: 00840619045524
• UDI-Public: (01)00840619045524(17)290301(10)13940100
• 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
• Report Date (Section B): 12/11/2024

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: 13940100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown