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

Model Number 10400

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Sample returned for analysis doesn't show any foreign object visible to naked eye or magnification, neither on the device nor inside the pouch.Required explanation to the customer but no answer has been received.

Event Description

Customer found a foreign object getting into the product before use.

• Brand Name: DRENTECH PUMP 100 ML
• Type of Device: SILICONE RESERVOIR 100 ML
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer (Section G): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer Contact: daniela malavasi ; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 8815054
• MDR Text Key: 151883343
• Report Number: 3013058659-2019-00004
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 10400
• Device Catalogue Number: 10400
• Device Lot Number: F1610047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• 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