MAUDE Adverse Event Report: MEDELA AG FREESTYLE FLEX BREAST PUMP EN FR ES; PUMP, BREAST, POWERED

Model Number 101037980

Device Problems Decrease in Suction (1146); Obstruction of Flow (2423)

Patient Problem Unspecified Infection (1930)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Customer service sent the customer a replacement device and return of her original device was requested for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.Based on the results of ca 11-001, it cannot be definitively concluded that the pump caused or contributed to the customer's mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4) for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

Event Description

On (b)(6) 2020, the customer alleged to medela llc that her freestyle flex breast pump had low suction and was causing her to have clogged ducts and mastitis.She additionally alleged she had seen a doctor regarding the mastitis.

Manufacturer Narrative

The device was returned and was evaluated with a medela lab kit on (b)(6) 2020, and it passed suction and cycle specifications.The customer's connectors were also returned and were found to be dirty during a visual inspection.Any foreign contaminants that hinder the device's ability to form an adequate vacuum seal could potentially result in lower suction.It is very difficult to determine exactly how much contamination under normal use is needed for pump vacuum to suffer, but it is a known failure mode causing low suction.The freestyle flex instructions for use details cleaning procedure for the parts and accessories.It is also a common troubleshooting item to check.

• Brand Name: FREESTYLE FLEX BREAST PUMP EN FR ES
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug,
• MDR Report Key: 10147899
• MDR Text Key: 195166637
• Report Number: 1419937-2020-00056
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451379807
• UDI-Public: 020451379807
• Combination Product (y/n): N
• PMA/PMN Number: K191653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101037980
• Device Catalogue Number: 101037980
• Device Lot Number: 160183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other