MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11 IN(28CM)APPX 0.97ML,SMALLBORE SET,NANOCLAVE,6-PORT NANOCLAVE MANIFOLD,BCV; STOPCOCK, I.V. SET

Catalog Number	AM6127
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used list # am6127 connected to an unknown, bifuse extension set were returned for evaluation.As received, one of the nanoclaves was observed to be separated from its manifold.The nano manifold clave and manofold body were not observed to be tacky, however a beach marks on both components were confirmed.A slightly bent spike was confirmed.The customer's complaint can be confirmed.The probable cause of the separation was due to an unintentional bending force applied during use.The probable cause of the bent spike cannot be determined.A device history record review could not be conducted because no lot number was identified.
Event or Problem Description
The event occurred on an unspecified date and involved a 11 in(28cm)appx 0.97ml,smallbore set,nanoclave,6-port nanoclave manifold,bcv.The clave reportedly snapped off the manifold and twisted off at the distal end with no manipulation or bending, etc.There was no report of any human harm.

• Brand Name: 11 IN(28CM)APPX 0.97ML,SMALLBORE SET,NANOCLAVE,6-PORT NANOCLAVE MANIFOLD,BCV
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22546902
• Report Number: 9617594-2025-01501
• Device Sequence Number: 12915366
• Product Code: FMG
• UDI-Device Identifier: 00887709086357
• UDI-Public: 00887709086357
• 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
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: AM6127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2025
• Initial Report FDA Received Date: 07/18/2025
• 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