MAUDE Adverse Event Report: TARGET GENERAL MERCHANDISE INC. MILK STORAGE BAGS; BREAST PUMP ACCESSORY, MILK EXPRESSION AID, VIA POSITIVE PRESSURE

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The breast milk storage bags have an exceedingly high rate of failure.More than half of the bags i have used have leaked, resulting in contamination of the contents during thawing and loss of the contents.Given the high rate of failure (33% of consumers), they should not be sold as milk storage bags for holding liquid contents for infants.(b)(6) on their website, there are a high number of reviews indicating the same failure indicating that the manufacturer is very aware that this is a problem consistent among all batches.Fda safety report id # (b)(4).

• Brand Name: MILK STORAGE BAGS
• Type of Device: BREAST PUMP ACCESSORY, MILK EXPRESSION AID, VIA POSITIVE PRESSURE
• Manufacturer (Section D): TARGET GENERAL MERCHANDISE INC. ; 33 south sixth street mailstop cc - 3403 ; minneapolis MN 55402
• MDR Report Key: 12446652
• MDR Text Key: 270989136
• Report Number: MW5103797
• Device Sequence Number: 1
• Product Code: PWA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1