MAUDE Adverse Event Report: OWENS AND MINOR HUGGIES LITTLE SNUGGLERS; SIZE 1, 8-14 LBS

Lot Number BI427617B

Device Problems Material Disintegration (1177); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Sharp metal shavings/shards discovered embedded in the fibers of several huggies little snugglers size 1 8-14 lb diapers.The affected diapers appear to be isolated to the same lot number.We have had one staff member poked and one pt poked as a result without serious harm or injury.Our facility is currently removing all known supply of this lot number from stock.Unk if any other lot numbers are affected at this time.Dates of use: (b)(6) 2014 to (b)(6) 2015.Reason for use: infant waste elimination storage product.Event abated after use stopped.

• Brand Name: HUGGIES LITTLE SNUGGLERS
• Type of Device: SIZE 1, 8-14 LBS
• Manufacturer (Section D): OWENS AND MINOR
• MDR Report Key: 4494785
• MDR Text Key: 5564500
• Report Number: MW5040625
• Device Sequence Number: 1
• Product Code: EYQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: BI427617B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 3