MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPC; STOPCOCK, I.V. SET

Catalog Number	AC135
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.E1 - this complaint was received through: (b)(6).The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to a 120" (305 cm) appx 15.8 ml, 15 drop admin set w/3 clave¿ clear, nanoclave¿ stopcock, 2 check valves, spin luer, 2 ext that experienced no flow during use.The reporter stated that the custom anesthesia set where the line primes fine and will administer fluid, suddenly stop working 1-2 hours in.This is very problematic as they have to pause patient care and change out the line, causing a pause in fluid delivery (which if anesthesia drugs are currently being administered could cause a major issue).They have three sets to send in for investigation.The anesthesia drugs and it's quantity used were unknown.
Event or Problem Description
The event occurred on an unspecified date.
Additional Manufacturer Narrative
The following items were provided from the customer for complaint investigaiton: -one used list# ac135 15 drop admin set -one new list# ac135 15 drop admin set -one new medikit supercath 5 20g, and one (1) new medikit supercath 5 18g.Each ac135 set was flow-tested to replicate clinical conditions.There were no issues priming, no leaks and no occlusions were observed, and flow was able to be established through the bag spike and each clave on both sets.The complaint of the set ceasing function was not replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in b5 - describe event or problem, d10 concomitant product and h6 health effect - impact code.

• Brand Name: 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPC
• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21334290
• Report Number: 9617594-2025-00235
• Device Sequence Number: 8459645
• Product Code: FMG
• UDI-Device Identifier: 00887709124417
• UDI-Public: (01)00887709124417(17)290901(10)14144071
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: AC135
• Device Lot Number: 14144071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: UNSPECIFIED FLUID/INFUSATE, MFR UNK.; UNSPECIFIED IV LINE, MFR UNK.
• Patient Sex: Unknown