MAUDE Adverse Event Report: REDAX SPA DRENTECH PUMP 100 ML; SILICONE RESERVOIR 100 ML

Model Number 10400

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Sample has not been returned for evaluation because the hospital scrapted it.Without sample is not possible to investigate on the root causes.Review of the production document (device history record), doesn't show any deviation of the process and qc inspection doesn't highlight problems on the valve or assembling phase.The lot has never been complained, even if all the units have been distributed on the market.Working by hypothesis, we can consider that the defect was caused by an incorrect assembling of the valve due to a mistake of the operator.The investigation is still in progress; in case of any further new information obtained, a supplemental report will be issued.

Event Description

The valve is fallen inside the silicone bulb.The drainage has been substituted.

• Brand Name: DRENTECH PUMP 100 ML
• Type of Device: SILICONE RESERVOIR 100 ML
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, 46025 ; IT 46025
• Manufacturer (Section G): REDAX SPA; via galileo galilei 18; poggio rusco, 46025 ; IT 46025
• Manufacturer Contact: daniela malavasi ; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 8975329
• MDR Text Key: 218738680
• Report Number: 3013058659-2019-00006
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/27/2024
• Device Model Number: 10400
• Device Catalogue Number: 10400
• Device Lot Number: F1901037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR