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

Catalog Number 688410/B

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

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 was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: BLOOD PRESSURE TRANSDUCER SET
• Type of Device: SAFEDRAW TRANSDUCER SET
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 12478342
• MDR Text Key: 271690929
• Report Number: 8020616-2021-00056
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884450359839
• UDI-Public: 884450359839
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/15/2021
• 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: 09/08/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention