MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS NESTABLE COLLECTOR 7.6L (6.7QT); SHARPS COLLECTOR

Catalog Number 300440

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the edges of a bd¿ sharps nestable collector 7.6l (6.7qt) were sharp.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Photos received.According to the dhr review process; the result showed there were no issues reported like collector with ¿edgy sides¿ during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like collector with ¿edgy sides¿ for the same part number throughout the last twelve months.According to the photo received, we confirmed the area that was reported by the end user in the complaint, however the side observed is known like ¿stacking ribs¿ is an essential part of the product, due to this side prevents damages caused by interaction between the bases stacked.In addition, no abnormality or warps was observed that could cause the function of the stacking ribs to be inadequate.Based on information provided was confirmed that the issue is not related to the manufacturing process since the concerning area is part of the product design.The concerning area is part essential of the product, due to prevent damages in the collectors.

Event Description

It was reported that the edges of a bd sharps nestable collector 7.6l (6.7qt) were sharp.There was no report of exposure, injury or medical intervention.

• Brand Name: BD¿ SHARPS NESTABLE COLLECTOR 7.6L (6.7QT)
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7643127
• MDR Text Key: 112730406
• Report Number: 2243072-2018-00470
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300440
• Device Lot Number: 7188937
• Date Manufacturer Received: 06/06/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other