MAUDE Adverse Event Report: COV LP/LLC, CRYSTAL LAKE, MFG SHARPSAFETY

Model Number 8506Y

Device Problem Defective Component (2292)

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

Event Date 04/09/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/22/17.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the sharps container is jamming so staff are being exposed to previous used sharps when attempting to dispose of other sharps.

Manufacturer Narrative

A device history record was not reviewed as a lot number could not be provided.As per the communication from the sales rep the container was not filled above the fill line.The winged infusion sets with flexible tubing and large syringes are being disposed of.The tubing gets stuck in the back of the container lid and the lid will no longer open once this happens.Also large syringes do not fit easily in the small lid opening and are hard to drop and cause the lid to get stuck when dropping.Based on the information provided, it appears that a different style of lid-container should be used in this type of setting.The root cause is determined to be customer misuse.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.This will be used for tracking and trending purposes.This issue has been determined to be an event with no user harm or injury.It may be different style lid/container opening unit should be used for customer¿s specific end use application.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: sharps container is jamming so staff are being exposed to previous used sharps when attempting to dispose of other sharps.

• Brand Name: SHARPSAFETY
• Manufacturer (Section D): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6581186
• MDR Text Key: 75816815
• Report Number: 1424643-2017-05008
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8506Y
• Device Catalogue Number: 8506Y
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1