MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

Model Number 9207010/57062

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/15/2015

Event Type  malfunction  

Event Description

Customer reported to a medela customer service rep that the back of her transformer for her pump in style advanced breast pump backpack fell off.There is a breach present, which is a safety risk.

Manufacturer Narrative

A replacement transformer was sent to the customer.The product involved in the complaint was not returned for eval/investigation at this time.No conclusion can be made as to the cause of the event.Should additional info or the original product be received, resulting in new, changed, or corrected info, a follow up report will be filed at that time.This issue with the damaged transformer housing for the pump in style device was addressed in investigation (b)(4) the investigation found that the transformers are being damaged during shipment from the manufacturer to medela.This damage is causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the transformers to medela is not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process has been modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength has also been increased to further protect the transformers during shipping.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4475029
• MDR Text Key: 5399882
• Report Number: 1419937-2015-00025
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/57062
• Device Catalogue Number: 9207010/57062
• Device Lot Number: REV L-1811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/15/2015
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1