MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE DTX SAFEDRAW KITS.GABARITH; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number 688396/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

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 [pm] set was found to be leaking between the red line and the extraction port.The pm set was exchanged for a new device, and the procedure was successfully completed.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.Visual inspection was conducted upon receipt of the returned device.The complaint is confirmed.The root cause is attributed to the manufacturing process likely caused by tolerance fitting between the tubing adaptor and planecta housing.A dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: DTX SAFEDRAW KITS.GABARITH
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 12313262
• MDR Text Key: 266219126
• Report Number: 8020616-2021-00049
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884450359792
• UDI-Public: 884450359792
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2022
• Device Catalogue Number: 688396/B
• Device Lot Number: C1975119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1