MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PERSONAL DBL SHOULDER BAG; PUMP, BREAST, POWERED

Model Number 57066

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusion can be made as to the cause of the event.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 her pump in style transformer looked warped.She alleged it had a crack on the side of it and a chunk broke off and cracked opened.Her husband taped it back together.She thinks her son dropped it and it fell and broke.

• Brand Name: BREASTPUMP PERSONAL DBL SHOULDER BAG
• 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: 6794960
• MDR Text Key: 82934530
• Report Number: 1419937-2017-00223
• 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: 08/15/2017

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: 57066
• Device Catalogue Number: 57066
• Device Lot Number: 9207010 REV M - 5012
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/24/2017
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• 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