MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number 8935Y

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/12/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states the containers were found cracked when the carton was opened.

• Brand Name: SHARPSAFETY
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7869936
• MDR Text Key: 120100730
• Report Number: 1424643-2018-00010
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 20884521022420
• UDI-Public: 20884521022420
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8935Y
• Device Catalogue Number: 8935Y
• Device Lot Number: 17J03663
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1