MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 7.6L YEL AU; SHARPS CONTAINER

Catalog Number 301273

Device Problem Break (1069)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that sharps coll 7.6l yel au needle got stuck and caused a needle stick injury.The following information was provided by the initial reporter: received a needlestick injury.She places the needles in downwards.The needles used for each patient have a label attached to it for identification.The label got stuck in the swing part of the container, and the needle flicked up and felt a prick from the needle.The swing on the container can sometimes not fully close if prodded gently.The container was quite full.She wasn¿t aware of the line indicator of how much she should have placed into the container.

Manufacturer Narrative

H6: investigation summary the customer provided photos of the affected sample with the complaint of needle stick injury.This complaint was escalated to the supplier for investigation for potential root cause.Dhr review process can¿t be performed because the lot number wasn¿t provided.Additionally, a ncmr (non-conformance material report) records review was performed for a period of twelve months (jul/2020 ¿ jul/2021), however there was not found records related to needle sticks or balance door failures for part number 301272.According with this investigation there is not enough information like a sample to understand the failure experimented by the customer in order to determine the root cause of this issue.With the information provided (complaint report) from the customer this issue was generated when the end user dropped the needles downwards and a needle label identification got stuck in the door of the top, after the door swung the needle flicked up and pricked the end user.Therefore, with this information it leads to a customer misuse because the ifu (instruction for use) states to drop sharp point-first horizontally through opening.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that sharps coll 7.6l yel au needle got stuck and caused a needle stick injury.The following information was provided by the initial reporter: ¿ received a needlestick injury.¿ she places the needles in downwards.¿ the needles used for each patient have a label attached to it for identification.¿ the label got stuck in the swing part of the container, and the needle flicked up and felt a prick from the needle.¿ the swing on the container can sometimes not fully close if prodded gently.¿ the container was quite full.She wasn¿t aware of the line indicator of how much she should have placed into the container.

• Brand Name: SHARPS COLL 7.6L YEL AU
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12054552
• MDR Text Key: 265890288
• Report Number: 2243072-2021-01736
• 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: 09/14/2021

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: 301273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other