MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE BREASTPUMP; PUMP, BREAST, POWERED

Model Number 67060

Device Problems Device Inoperable (1663); Defective Component (2292)

Patient Problem Bacterial Infection (1735)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Replacement parts were sent to the customer.In follow up with the customer, she indicated that the replacement parts were working without issue and the mastitis was resolved.Based on the results of (b)(4), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis."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) 2017, the customer alleged to medela llc that she bought three sets of spare parts for her freestyle breast pump and they did not work.She alleged that she had mastitis for which she was prescribed an antibiotic.

Manufacturer Narrative

The customer returned the connectors and barriers for evaluation, which was performed on 11/30/2017 and it was determined that the root cause of the customer's low suction issue can be attributed to a molding deficiency on the connectors sealing surface.Currently there is an open investigation (capa (b)(4)), which identified molding enhancements to correct this deficiency, which were put in place in july of 2017.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7068517
• MDR Text Key: 93283798
• Report Number: 1419937-2017-00334
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K150499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67060
• Device Catalogue Number: 67060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/02/2017
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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