MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4-WAY NANOCLAVE® STOPCOCK (RED RING),; STOPCOCK, I.V. SET

Model Number	AC123
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation is anticipated, but not yet begun.
Event or Problem Description
The event occurred on an unknown date.The report stated that an unspecified amount of blood loss occurred during use of a trifuse extension tubing, during an unspecified clinical procedure.The tubing pulled out from the connector where is attaches to the hub and resulted in blood loss.There was patient involvement, however, there was no harm to the patient.The trifuse extension was replaced and no further issues were reported.
Additional Manufacturer Narrative
H10: one (1) used ac123, trifuse ext set (lot # 4375451) and one (1) new, packaged ac123, trifuse ext set (lot # 4375451) were received and visually inspected.As received, the male luer was missing from the used extension set.A solvent ring on the end of the tubing was identified indicating the tubing was bonded at one time.No manufacturing related defects were seen on the used set.No apparent damage or anomalies were present on the new, unused ac123 set.The unused extension set was functionally tested and met product performance specifications.No leakage or disconnection was observed.The reported complaint of tubing separation was confirmed on the returned used ac123 device.The probable cause is an unintentional excessive pulling force at the bonded connection during use.The dhr (device history review) for lot number 4375451 was reviewed and there were no relevant non-conformances found.

• Brand Name: 12" TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 4-WAY NANOCLAVE® STOPCOCK (RED RING),
• 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
• MDR Report Key: 9375029
• Report Number: 9617594-2019-00408
• Device Sequence Number: 13567780
• Product Code: FMG
• UDI-Device Identifier: 00887709075887
• UDI-Public: (01)00887709075887(17)240901(10)4375451
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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 Expiration Date: 09/01/2024
• Device Model Number: AC123
• Device Catalogue Number: AC123
• Device Lot Number: 4375451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1