MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS DISPOSAL BY MAIL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 323488

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is premium plastic solution.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date : unknown.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd sharps disposal by mail container had no lid.The following information was provided by the initial reporter : material no.323488.Batch no.0255001.It was reported that lid was missing when preparing to return by mail for disposal.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.

Event Description

It was reported that 1 bd sharps disposal by mail container had no lid.The following information was provided by the initial reporter : material no.323488 batch no.0255001.It was reported that lid was missing when preparing to return by mail for disposal.

• Brand Name: BD SHARPS DISPOSAL BY MAIL
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11829672
• MDR Text Key: 256728711
• Report Number: 2243072-2021-01487
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K943137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: 323488
• Device Lot Number: 0255001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2021
• Initial Date FDA Received: 05/15/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1