MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 17L YELLOW; SHARPS CONTAINER

Catalog Number 303209

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is hdq us (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the sharps coll 17l yellow experienced sharp protrusion through sharp container wall during use.Product defect resulted in a dirty needle stick injury.It has not been mentioned whether medical intervention was applied as a result.The following information was provided by the initial reporter: needle pierced container.30g needle pierced container and resulted in needle stick injury to staff member.Container was reported to be only one quarter filled.

Event Description

It was reported that the sharps coll 17l yellow experienced sharp protrusion through sharp container wall during use.Product defect resulted in a dirty needle stick injury.It has not been mentioned whether medical intervention was applied as a result.The following information was provided by the initial reporter: needle pierced container.30g needle pierced container and resulted in needle stick injury to staff member.Container was reported to be only one quarter filled.

Manufacturer Narrative

H6: investigation summary the collectors are needle puncture resistant, not puncture proof.Retain samples of the lot were tested and show the collectors meet specification.Retain samples of the batch 20204006 were referred to and wall thickness measurements by magna mike showed no wall thickness deviation below the wall thickness minimum specification of 1.18mm.A device history review was conducted for lot number 20204006.Without additional evidence like a picture of the penetration or the actual sample no further investigation was possible.

• Brand Name: SHARPS COLL 17L YELLOW
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10690807
• MDR Text Key: 211714509
• Report Number: 2243072-2020-01666
• 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: 02/09/2021

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: 303209
• Device Lot Number: 20204006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other