MAUDE Adverse Event Report: ICU MEDICAL INC. CATH LAB KIT

Model Number	46098-75
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the mfg.Lot build database for the reported lot# 3407711 (mfg.03/2017) showed (b)(4) units were mfg., tested, inspected and released.There were no exception documents generated during the lot build.The 46098-75 kit device/components were pre-tested/primed prior to placement, at a unspecified time the product issue (particulate) was detected by attending clinician.The device was removed/replaced.Although there was an unscheduled device change out there was no critical delay in therapy; no change in pts.Baseline condition and or no emergent medical treatments and or interventions were required.The involved device/component were not returned for analysis and confirmation.The exact cause(s) of the reported event is unknown.
Event or Problem Description
Voluntary event report mw 5070799 received reporting particulate issue(s) with use of one 46098-75 cath lab kit.The mw 5070799 report describes the (b)(6) 2017 event as follows ".During a procedure, the physician noted a small piece of plastic in the fluid after he had pulled back on the syringe which was attached to the manifold.Origin of the plastic is unk but may have originated in the manifold.Syringe appears intact." although additional event information and device return status were requested facility had no additional event information or the location / status of the involved device.

• Brand Name: CATH LAB KIT
• Common Device Name: CATH LAB KIT
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6909395
• Report Number: 2025816-2017-00181
• Device Sequence Number: 717600
• Product Code: DQO
• UDI-Device Identifier: 00887709049628
• UDI-Public: 00887709049628
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K052865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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: Physician
• Device Expiration Date: 03/01/2020
• Device Model Number: 46098-75
• Device Catalogue Number: 46098-75
• Device Lot Number: 3407711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1