MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 5.1L NEXT GEN YELLOW AU; SHARPS COLLECTOR

Catalog Number 301272

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed, and (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the sharps coll 5.1l next gen yellow au had a sharp molding defect and the consumer cut their finger on it.There were 20 sharps collectors reported to have had this defect.The following information was provided by the initial reporter, "cut finger whilst unpacking 2 rows of containers are placed close to each over and stacked upside down one of the top of the other inside the carton so as i was pulling out the stock, my finger was cut.Band-aid applied.".

Manufacturer Narrative

H.6.Investigation: the actual product was not returned and photo representation could not be provided for investigation.A review of the device history record (dhr) could not be performed since the lot was unknown.A review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and there were no related issues recorded (e.G.Flash) that may cause an injury by the manufacturer for the part number.The failure mode cannot be determined as related to the manufacturing process.The root cause for the reported issue was unknown and could not be determined with the information available.H3 other text : see h.10.

Event Description

It was reported that the sharps coll 5.1l next gen yellow au had a sharp molding defect and the consumer cut their finger on it.There were 20 sharps collectors reported to have had this defect.The following information was provided by the initial reporter: "cut finger whilst unpacking.2 rows of containers are placed close to each over and stacked upside down one of the top of the other inside the carton so as i was pulling out the stock, my finger was cut.Band-aid applied".

• Brand Name: SHARPS COLL 5.1L NEXT GEN YELLOW AU
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10891013
• MDR Text Key: 217967807
• Report Number: 2243072-2020-01913
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301272
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1