MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number 101041361

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

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning and reassembling the kit and tubing set; and inspected the transformer for damage.The troubleshooting did not resolve the issue.A replacement device was sent to the customer.In follow up with a complaint handler on(b)(6) 2021.The customer indicated that she developed a clogged duct and was prescribed an antibiotic, which is now clear.She indicated that the replacement pump was working and the overall suction is better but she still feels that the pump is louder and there is more vibration with her replacement than her original one.The customer indicated that the pump may have been damaged in delivery or been delayed in sitting on a delivery truck due to weather and should have bee marked fragile.The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on (b)(6) 2021 and it passed suction and cycle specifications.The customer's report of low suction could not be confirmed.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).

Event Description

On (b)(6) 2021.The customer alleged to medela llc that her pump in style breast pump had low suction and the vibration sounds like a jack hammer unless placed on a pillow.Additionally, she alleged that she had a clogged duct and went to the doctor.

• Brand Name: PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry, il
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 11465999
• MDR Text Key: 248198306
• Report Number: 1419937-2021-00018
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101041361
• Device Catalogue Number: 101041361
• Device Lot Number: 0000011409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other