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

Catalog Number 303209

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a needle pierced through sharps coll 17l yellow.This was discovered during use.The following information was provided by the initial reporter: needle pierced through sharps collector.Needle has pierced through sharps collector and nurse received needle stick injury.The nurse required gluing of the laceration to her leg and is currently awaiting blood results.

Manufacturer Narrative

H.6.Investigation summary: customer reported a single needle penetration of the container wall that has led to a nsi.Pictures of the needle through container were provided.Needle has pierced through sharps collector and nurse received needle stick injury.The nurse required gluing of the laceration to her leg and is currently awaiting blood results.Measurements of retain samples of the manufacture batch in question 20059006 cavities 1 & 2 have shown wall thickness measurements in the area of concern to be above the buy specification and manufacturing specification.A device history review was conducted for lot number 20059006.The containers are puncture resistant and not puncture proof.If significant force is used to push the needle into the container it may be possible to penetrate the container wall.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.H3 other text : see h.10.

Event Description

It was reported that a needle pierced through sharps coll 17l yellow.This was discovered during use.The following information was provided by the initial reporter: needle pierced through sharps collector.Needle has pierced through sharps collector and nurse received needle stick injury.The nurse required gluing of the laceration to her leg and is currently awaiting blood results.

• 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: 10288879
• MDR Text Key: 202063214
• Report Number: 2243072-2020-01081
• 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: 10/01/2020

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: 20059006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention