MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 8 OUNCE BOWL SPINAL CUP; GENERAL SURGERY TRAY

Model Number DYND50310

Device Problems Break (1069); Sharp Edges (4013)

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

Event Date 03/27/2019

Event Type  malfunction  

Event Description

Upon opening a medline, sterile, 8 ounce bowl (spinal cup), i noticed that the side of the bowl was broken.The part that broke off exposed a sharp edge on the cup.The packaging was not compromised and the product was sterile.Because of the break, the bowl was not able to be used.The product was removed from the field.

• Brand Name: 8 OUNCE BOWL SPINAL CUP
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; mundelein IL 60060
• MDR Report Key: 8470857
• MDR Text Key: 140754376
• Report Number: MW5085436
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND50310
• Device Catalogue Number: DYND50310
• Device Lot Number: 18JAA457
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1