MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 1.4L YELLOW TRAY SIZE; SHARPS CONTAINER

Catalog Number 303205

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing location for this product is hdq us (b)(4).This site is an oem manufacturing site.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that sharps coll 1.4l yellow tray size was perforated by a needle and caused a needlestick injury.The following information was provided by the initial reporter: sharps container was perforated by a needle sharp, staff member sustained needlestick injury.The sharps container was not overfull and when i shook the container gently, it was mainly filled with purple unistik safety lancets.It appeared to be a solid tip but had been splayed from pushing through the plastic.A staff member sustained a needle stick from the sharp and they have the staff member on their bbfe follow up.The sharps container has been disposed of in the theatre sharps bin to avoid further bbfe.

Manufacturer Narrative

H6: investigation summary: 3 photos were received and presented to the supplier in representation of this complaint.After multiple attempts the dhr was not available after multiple attempts to retrieve it.According to this investigation, retained samples of the same batch were retrieved and the wall thickness was above the minimum specifications of 1.2mm, measuring between 1.6 and 1.7mm.These containers are designed to withstand a force of 12.5n (newtons) before penetration is achieved.It is believed that the root cause of this failure was a force which exceeded this minimum threshold while needles were disposed.

Event Description

It was reported that sharps coll 1.4l yellow tray size was perforated by a needle and caused a needlestick injury.The following information was provided by the initial reporter: sharps container was perforated by a needle sharp, staff member sustained needlestick injury.The sharps container was not overfull and when i shook the container gently, it was mainly filled with purple unistik safety lancets.It appeared to be a solid tip but had been splayed from pushing through the plastic.A staff member sustained a needle stick from the sharp and they have the staff member on their bbfe follow up.The sharps container has been disposed of in the theatre sharps bin to avoid further bbfe.

• Brand Name: SHARPS COLL 1.4L YELLOW TRAY SIZE
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11340711
• MDR Text Key: 232558912
• Report Number: 2243072-2021-00345
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303205
• Device Lot Number: 20275001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other