MAUDE Adverse Event Report: DTX PLUS SAFEDRAW¿; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number	10884450544157
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that after the priming of the unit as usual before use, it was started to be used for the patient.No leakage was found at that time.During operation, heparinized saline leaked out from a bonded junction between a transducer and an infusion line upstream.The user did not tap or overtighten the junction before use.It is unknown whether the junction was actually bonded and whether it had a crack.No patient injury.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: DTX PLUS SAFEDRAW¿
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• MDR Report Key: 12586106
• Report Number: 8020616-2021-00067
• Device Sequence Number: 3632472
• Product Code: DXN
• UDI-Device Identifier: 10884450544157
• UDI-Public: 10884450544157
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K935782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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 Model Number: 10884450544157
• Device Catalogue Number: 687633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1