MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6 INCH MONITORING EXTENSION SET; INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES

Catalog Number	424080411
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the event is expected to be returned to the manufacturer for further evaluation however it has not yet been received.As additional information is received, a supplemental report will be issued.
Event or Problem Description
It was reported that blood was leaking from the hub of the extension set where it connects to the patient.No harm to the patient was reported.No additional information is available at this time.
Additional Manufacturer Narrative
H10: the reported complaint of leakage was not confirmed on either the used or new the monitoring kit extension sets.Both were pressure leak tested per the product specifications and performed as expected with no leads observed.A device history review (dhr) for the reported lot was performed and relevant commodities were reviewed.No non-conformances were found that would have contributed to the reported complaint.G1: (b)(4); h3: yes.

• Brand Name: 6 INCH MONITORING EXTENSION SET
• Common Device Name: INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES
• 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: 8445895
• Report Number: 9617594-2019-00098
• Device Sequence Number: 3013861
• Product Code: DRS
• UDI-Device Identifier: 00840619027964
• UDI-Public: (01)00840619027964(17)210801(10)3759626
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 08/01/2021
• Device Catalogue Number: 424080411
• Device Lot Number: 3759626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1