MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number 57062

Device Problems Component Falling (1105); Crack (1135); Structural Problem (2506)

Patient Problem No Information (3190)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement power supply and return of her original power supply was requested for testing/evaluation.In follow up with the customer on (b)(6) 2017, the customer reported that there was no breach in the power supply housing at time the original report was made.The prong on the right side retracted inside the unit.After making the report and when trying to retrieve the prong, a hairline crack began to form.Then when the power supply was placed on the counter, the crack become larger, causing the section to break off.Causing the inside circuitry to be visible.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they were being damaged during shipment from the manufacturer to medela.This damage was causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the power supply to medela was not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process was modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength was also increased to further protect the power supply during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.

Event Description

On (b)(6) 2017, the customer alleged that the power supply housing for her pump in style breast pump was cracked and that the prongs were damaged and fall into the housing when attempting to plug the pump in.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• 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: 6764857
• MDR Text Key: 82588584
• Report Number: 1419937-2017-00217
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Device Lot Number: 9207010 REV M - UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/13/2017
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/03/2017
• 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