MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number 57081

Device Problem Increase in Suction (1604)

Patient Problem Pain (1994)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.During follow up with a complaint handler on (b)(6) 2017, the customer indicated that she had very pink, sore nipples and areolas, with some bruising, about which she spoke with her physician, who prescribed an all-purpose nipple ointment.She alleged that the ointment did not help and she met with a lactation consultant, who provided her with different sized breast shields to try.She still is not sure that she has the correct breast shield fit; however, the pain has lessened.She confirmed that the replacement pump was working without issue and requested to be put in touch with medela clinical staff.As of the date of this report, medela clinical staff was not successful at making contact with the customer.The device was received on (b)(6) 2017 and evaluated on (b)(6) 2017.The pump was returned with the power supply and the customer's parts/accessories.The power supply was not producing any output voltage, so the pump was tested with a lab power supply.The evaluation identified a missing flag, which confirmed the customer's report of high suction.A review of the device history record for this pump indicated that the device passed vacuum and cycle testing on (b)(6) 2017, when it was released from production.On (b)(6) 2018, contact was made with the customer to verify that the pump worked fine when she initially used it, which would support the fact that the missing flag found during the product evaluation was there when released from production.The customer verified that the pump worked without issue for the first 8 days that she used it and indicated that she was not aware of any impact to the pump that would have caused damage to the flag.

Event Description

On (b)(6) 2017, the customer alleged to medela llc that the suction was high on her pump in style breast pump, which was causing pain while pumping.

• Brand Name: BREASTPUMP PNSA STARTER
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7168617
• MDR Text Key: 96518991
• Report Number: 1419937-2018-00006
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• 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
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Device Lot Number: 438074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Distributor Facility Aware Date: 11/28/2017
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other