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

Model Number	101035077
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service provided the husband with information regarding the pump in style being a closed system.The husband wanted to know what his options were on returning the pump and getting a different brand.The customer service representative went over the warranty process and offered to troubleshoot the pump and informed on the importance of proper cleaning of the pump and parts.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2021, the customer indicated that the staph infection started about 2 months ago and she was prescribed antibiotics.The customer also indicated that she had received her replacement pump but hadn't tried it yet because she was waiting on a different size breast shield.She also indicated that she wanted to try her replacement pump before sending back her old one.Follow up with the customer is ongoing.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2020, the customers' husband alleged to medela llc that his wife had a staph infection, which they were told by their lactation consultant was attributed to the use of the pump in style breast pump that she believed was an open system.Additionally, he alleged that his wife was prescribed medication.

• Brand Name: PNSA STARTER BP EN ES USA
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 11203573
• Report Number: 1419937-2021-00002
• Device Sequence Number: 14181898
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 020451350776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 0000014265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other