MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1478
Medical Device Problem Code	No Flow (2991)
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, and 01 jan 2024 has been used as a placeholder.D4 and h4 the lot#, expiration date, and manufacture date are unknown.D4 - possible lot#13766524 - expiration date: 1 sep 2028 - manufacture date 14 sep 2023.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to a 7" smallbore ext set w/1.2 micron filter, clamp, rotating luer that experienced no flow during use.The reporter stated that the b1478 was clotting between 12-15 hours.The account could no longer filter lipids due to the increased risk of clabsi caused by additional disconnections of the filter during patient use.Then, when an icu medical clinical sales consultant visited the site on (b)(6) 2024, stated that lipids were not being filtered currently as they complain that the b1478 does not have the 24-hour longevity.It was also stated that it clots off at the 12¿15-hour mark.The event date is ongoing approximately for one calendar year.Status was during patient use.Sample is available for evaluation.There was patient involvement, no human harm and unknown in delay in therapy.
Additional Manufacturer Narrative
Received one used list#: b1478, 7" smallbore ext set w/1.2 micron filter, clamp, rotating luer.No visual damages or anomalies were observed.The reported complaint of clotting could not be confirmed.The sample flowed at gravity pressure without any issues.The returned sample was tested and performed to product specifications.The directions for use (dfu) states: ivfe or tna (3-in-1) solutions containing lipids must be administered using a 1.2 micron filter.Sets with these filters should be changed at least every 24-hours.A filter that clogs during infusion should be replaced.Attempting to clear the filter with pressure may lead to breakage.The possible lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" SMALLBORE 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: 20767743
• Report Number: 9617594-2024-01681
• Device Sequence Number: 9302921
• Product Code: FMG
• UDI-Device Identifier: 00887709001916
• UDI-Public: 00887709001916
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/13/2025

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: B1478
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 01/13/2025
• 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