MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS VALVE, 10 C; INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES

Catalog Number	46115-10
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for further investigation but has not yet been received.As additional information is obtained, a supplemental report will be submitted.
Event or Problem Description
It was reported that the device involved in the event became disconnected at a site below the stopcock during use on a patient.The reporter stated, the patient loss an unspecified amount of blood due to the disconnection.There was reported to be a delay in critical therapy but no other harm to the patient is known at this time.
Additional Manufacturer Narrative
The reported complaint of the tubing separation was confirmed.The cause of the tubing separation appears to be due to the uv adhesive at the bond between the arterial tubing and female luer was not fully cured.This defect was due to a manual manufacturing process error in ensenada.The device history review (dhr) for the reported lot showed no non-conformances that would have contributed to the reported complaint.Mfr site: (b)(6), date rec'd by manufacture: 4/18/2019, device evaluated by mfr: yes.
Additional Manufacturer Narrative
No product or sister samples were returned for investigation.Additionally, no pictures or videos were provided by the customer documenting the reported issue.Therefore, a comprehensive investigation cannot be conducted and a root cause can not be evaluated.The device history files were reviewed and no non-conformances or anomalies were found that would have contributed to the reported issue.New, reportable information was obtained on 3/22/2019.Date rec¿d by mfr - 3/22/2019.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS VALVE, 10 C
• 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: 8363280
• Report Number: 9617594-2019-00042
• Device Sequence Number: 1959272
• Product Code: DRS
• UDI-Device Identifier: 00887709082496
• UDI-Public: (01)00887709082496(17)211101(10)3854909
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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: 11/01/2021
• Device Catalogue Number: 46115-10
• Device Lot Number: 3854909
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019; 01/31/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/16/2019; 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1