MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS LLC PEEL POUCH UTILITY BOWL 32 OUNCE STERILE; BASIN, STERILE

Catalog Number 01232

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 04/06/2017

Event Type  malfunction  

Event Description

This facility recently changed to a new vendor for single-use peel pouch 32 ounce bowls.The bowls have a plastic pouch with a paper peel-away top (previous product had a plastic peel-away top).The staff is finding that the paper tops are easily damaged.So far, three bowls have had to be discarded because of damaged tops and one was found to have a slit opening in the paper top.Staff are concerned that they may not be seeing smaller defects which would affect sterility.

• Brand Name: PEEL POUCH UTILITY BOWL 32 OUNCE STERILE
• Type of Device: BASIN, STERILE
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS LLC; 209 medegen dr.; gallaway TN 38036
• MDR Report Key: 6493073
• MDR Text Key: 72797401
• Report Number: 6493073
• Device Sequence Number: 1
• Product Code: FNY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2017,04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 01232
• Device Lot Number: 226894
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1