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	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where a tube separation from the inlet filter is observed, the customer is also shown the item and lot information, and no additional anomalies besides the mentioned are observed.Based on the device history review (dhr) lot review of the lot in this complaint, it was confirmed that the issue is related to insufficient solvent applied during manual process assembly in ensenada.The dhr lot#13847714 was reviewed, and non-conformities were found that would have led to the reported condition on the complaint.D9 - device available for evaluation: no.
Event or Problem Description
The complaint/event involved a 8" (20 cm) ext set w/1.2 micron filter, clamp, rotating luer.The 1.2 microfilter reportedly 'broke off the blue part of the filter piece' and this resulted in leaking total parenteral nutrition (tpn).The tpn infusion was then stopped the rest of the tubing was examined and it looked patent.The materials department was called to replace the filter.The customer wiped the ends down with an alcohol pad and restarted the tpn infusion.Pharmacy supplied a new filter and the tpn was not wasted.The patient was sleeping at the time of the event and no known factors contributed to the filter coming apart.There was no report of human harm, however there was an unspecified delay in therapy due to the required infusion pause, and the need for a new filter for replacement and then restarting the patient's infusion.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e initial reporter full phone: (b)(6).

• 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: 20027471
• Report Number: 9617594-2024-01169
• Device Sequence Number: 15315576
• Product Code: FMG
• UDI-Device Identifier: 00887709000087
• UDI-Public: (01)00887709000087(17)281201(10)13847714
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/23/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION, MFR UNK
• Patient Sex: Unknown