MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SHARPS DISPOSAL CONTAINER; SHARPS CONTAINER

Catalog Number 303209

Device Problem Defective Device (2588)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H3.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 that bd sharps disposal container was damaged.The following information was received by the initial provider with the verbatim: we have an issue with the 17lt yellow sharps, ref # (b)(4).We have had 3 returned to us as the lids cannot be opened, these are all the same batch, being 22336006.

Event Description

Imdrf codes must be updated.

• Brand Name: BD SHARPS DISPOSAL CONTAINER
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18089269
• MDR Text Key: 327629728
• Report Number: 2243072-2023-02014
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2024

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: 303209
• Device Lot Number: 22336006
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 07/30/2024
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1