MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 114" 10 DROP PRIMARY SET W/3 MICROCLAVE®, REMV 3-PORT NANOCLAVE® MANIFOLD W/CHEC; STOPCOCK, I.V. SET

Catalog Number	AM3011
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 114" 10 drop primary set w/3 microclave®, remv 3-port nanoclave® manifold w/check valve, spin luer, 1 ext that experienced cracks and leakage.The reporter stated that they had a few more lines cracked in the packages.These are being opened in a new pack and we find that the product is cracked.It has happened on multiple dates.They go back with the patient and as they are putting the patient to sleep, meds are running out.They have been multiple defective items.
Additional Manufacturer Narrative
The initial reporter indicated that the event occurred multiple times and that they have 8 defective devices; however, no additional information was given pertaining to the additional instances.A search of the complaint database showed no prior report of these events.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Additional information d9: device was received 5/13/2025.Investigation summary: received one (1) used am3011, one (1) new am3011 and four (4) open/unused am3011 for inspection.The female luer on each of the samples was cracked.A crack was observed on the female luer of the new set in the sealed packaging.The reported complaint can be confirmed.The probable cause is due to manufacturer molding error.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 114" 10 DROP PRIMARY SET W/3 MICROCLAVE®, REMV 3-PORT NANOCLAVE® MANIFOLD W/CHEC
• 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: 21946625
• Report Number: 9617594-2025-00880
• Device Sequence Number: 13042066
• Product Code: FMG
• UDI-Device Identifier: 00887709086005
• UDI-Public: (01)00887709086005(17)290801(10)14115178
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/20/2025

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: AM3011
• Device Lot Number: 14115178
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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
• Patient Sex: Unknown