MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR; SHARPS DISPOSAL

Catalog Number 300450

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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.

Event Description

It was reported that 3 of the bd sharps collectors were missing the plastic lids.The following information was provided by the initial reporter: as per account, the large sharp containers 308-300450 i got 12 of the jars but only 9 of the lids so i was missing 3 plastic lids.

• Brand Name: BD SHARPS COLLECTOR
• Type of Device: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16598989
• MDR Text Key: 312014727
• Report Number: 2243072-2023-00453
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1