MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC MONITORING KIT; SAFESET MONITORING KIT

Lot Number	3327313
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Arterial line safeset syringe plunger came apart and was non-functional.Black robber stopper was detached from syringe.Blood was backed up in the syringe and unsure if air was present.Safeset changed.No harm to pt.Also noted in other safesets that the rubber sleeve inside the syringe detached from its anchor point.

• Brand Name: TRANSPAC MONITORING KIT
• Common Device Name: SAFESET MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL; san clemente CA 92673
• MDR Report Key: 6063184
• Report Number: MW5065653
• Device Sequence Number: 19031074
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/26/2016

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: 09/01/2019
• Device Lot Number: 3327313
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR