MAUDE Adverse Event Report: MEDELA LLC PNSA STARTER BP EN ES USA; PUMP, BREAST, POWERED

Model Number 101035077

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

The customer was sent new breast shields, connectors, valves, membranes, bottles and tubing.In follow up with a complaint handler on 08/10/2020, the customer indicated that she and her baby developed thrush on (b)(6) 2020 and the doctor prescribed a nipple cream for her and nystatin for her baby.She indicated that the replacement parts that she received were working without issue and the thrush had since cleared up for both of them.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).It cannot be definitively concluded that the pump caused or contributed to the customer's thrush.Reported issues of thrush were investigated under (b)(4) and the root causes were identified as: lack of education/training to mothers on breast feeding and breast milk pumping.Insufficient guidance on breast shield sizing to prevent nipple trauma.Insufficient personal hygiene practices prior to breast milk pumping or breast feeding; and no access to or not following the manufactures' instructions for the cleaning and sanitation of the breast milk pumping components.No corrective actions resulted as it was determined that detailed instructions are available and adequate in both printed and on-line formats for cleaning breast milk pumping equipment, personal hygiene, proper breast shield sizing to prevent nipple soreness/trauma, which can lead to skin breaches, allowing for the potential introduction of yeast.

Event Description

On (b)(6) 2020, the customer alleged to medela llc that she had thrush and was advised by her lactation consultant to replace all of the parts for her pump in style breast pump.

• Brand Name: PNSA STARTER BP EN ES USA
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry, il
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry, il
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 10485577
• MDR Text Key: 205542668
• Report Number: 1419937-2020-00093
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 020451350776
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 0000001001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other