MAUDE Adverse Event Report: COVIDIEN CONTAINER BIOHAZARD 12GL SHARP; CONTAINER, SHARPS

Model Number 8935

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that there was a crack on the lid and body of the sharps container.

Manufacturer Narrative

Section d4: unique identifier (udi) # has been corrected to (b)(4).

• Brand Name: CONTAINER BIOHAZARD 12GL SHARP
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9771532
• MDR Text Key: 181539796
• Report Number: 1424643-2020-00568
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 30884521022489
• UDI-Public: 30884521022489
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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: No Information
• Device Model Number: 8935
• Device Catalogue Number: 8935
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 02/28/2020
• Patient Sequence Number: 1