MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET

Catalog Number 688410/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring set was found to be leaking between the artery puncture needle and the safedraw connection.Blood was seen in the bed and clinician chose to give the patient a transfusion.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.Functional testing was performed.The complaint could not be confirmed due to no leakage was observed.The root cause could not be determined however, it is likely that all connections to the patient were not frequently checked by the attending medical staff / loose connection [use error].The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.".

• Brand Name: SAFEDRAW TRANSDUCER SET
• Type of Device: BLOOD PRESSURE TRANSDUCER SET
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• MDR Report Key: 12362475
• MDR Text Key: 267965205
• Report Number: 8020616-2021-00052
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 04589867113482
• UDI-Public: 4589867113482
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Catalogue Number: 688410/B
• Device Lot Number: C2045130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention