MAUDE Adverse Event Report: URINE METER; URINE FLOW OR VOLUME MEASURING SYSTEM

Model Number 158100510190

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed a product malfunction.The device was not used.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

Complaint received from distributor reporting, "due to transportation problems, resulting in nine products damaged, after communication with the agents, the final replacement of nine products.Did not cause harm to patients, no equipment combined use." it was further reported that the damage was to the primary package of the product.No further information has been provided, nor any pictures.

Manufacturer Narrative

Additional information was requested about the reported complaint issue but, no more information about the type of damage and the number of boxes involved was obtained.A batch record review was performed.No non- conformance record related to complaint issue were initiated for complaint order.The batch record review resulted in discrepancy which was investigated.No sample was received for the complaint.The investigation concludes that the true root cause for the issue ¿damaged primary pack¿ cannot be identified.The potential root causes could be as listed: ¿ carrier mistake during transportation ¿ unsuitable way of packing into the shipper the change of the items orientation in the shipper and dividers using between the products is now in progress.New packing way was approved.No additional actions are recommended at the moment.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.(b)(4).

• Brand Name: URINE METER
• Type of Device: URINE FLOW OR VOLUME MEASURING SYSTEM
• MDR Report Key: 6699856
• MDR Text Key: 79653869
• Report Number: 3007966929-2017-00034
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: 158100510190
• Device Lot Number: 488936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1