MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS CONTAINER; SHARPS COLLECTOR

Catalog Number 367202

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd¿ sharps container there was an issue with lid won¿t shut.There was no report of injury or further medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.Non-conformity is collector has a warped/damaged cap and caps cannot be warped or damaged.Reviewed of the compliant with all personnel performed and started an investigation and reviewed in-process inspection.Spot checking for caps in stock was performed and no warped or damaged caps were found.The rework included removing each cap from the box and visually inspect for warpage or damage to cap.All acceptable cap repacked into new box.A total of 25965 pcs were reviewed in rework with all found acceptable.After reviewing all device history records, in house stock with no issues found and photo received from customer it is believed that the cap could have been damaged during shipping or misused.Damaged in transit or misuse.At this time a capa cannot be completed because of findings from investigation, however all personal was made aware of the complaint and are looking for any similar issues during next run of production.

Event Description

It was reported with the use of the bd sharps container there was an issue with lid won¿t shut.There was no report of injury or further medical intervention.

• Brand Name: BD¿ SHARPS CONTAINER
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7754478
• MDR Text Key: 116560116
• Report Number: 2243072-2018-01040
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367202
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other