MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL¿ 1.4L YELLOW N/V TRAY SIZE; SHARPS CONTAINER

Catalog Number 305331

Device Problems Material Protrusion/Extrusion (2979); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that needle protruding through bottom of sharp collector and nurse sustained needle stick injury with a bd sharps coll¿ 1.4l yellow n/v tray size.The following information was provided by the initial reporter: the nurse was carrying the sharps collector against her body and sustained a needle stick injury.There was a needle protruding through the bottom/side of the sharp collector.The collector was not completely full; however, it did contain at least 2 x10 ml and 1 x 20 ml syringe.

Event Description

It was reported that needle protruding through bottom of sharp collector and nurse sustained needle stick injury with a bd sharps coll¿ 1.4l yellow n/v tray size.The following information was provided by the initial reporter: the nurse was carrying the sharps collector against her body and sustained a needle stick injury.There was a needle protruding through the bottom/side of the sharp collector.The collector was not completely full however it did contain at least 2 x10 ml and 1 x 20 ml syringe.

Manufacturer Narrative

Investigation: the containers manufactured for use are puncture resistant and not puncture proof.The minimum wall thickness of 1.2mm is to withstand a penetration force of 12.5n/m.Incorrect use or forcing of needles into the containers that exceed this force can result in penetration of the container walls.The minimum wall thickness of 1.2mm is to withstand a penetration force of 12.5n/m.Incorrect use or forcing of needles into the containers that exceed this force can result in penetration of the container walls.The minimum wall thickness measured from retain sample was: cavity #1 - 1.32mm, cavity #2 - 1.30mm.The container meets requirements.

• Brand Name: BD SHARPS COLL¿ 1.4L YELLOW N/V TRAY SIZE
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8508772
• MDR Text Key: 141750369
• Report Number: 2243072-2019-00720
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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: Health Professional
• Device Catalogue Number: 305331
• Device Lot Number: 18227002
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other