MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 7.6L 24; SHARPS CONTAINER

Catalog Number 5460-ZKP

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the 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.Date of event: unknown.Medical device expiration date: na.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 when using the bd sharps coll 7.6l 24 the lid was difficult to close and seal.The following information was provided by the initial reporter.The customer stated: the "cover of the 7.6l sharp box is difficult to seal.".

Manufacturer Narrative

Oem manufacturer: the 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.Date of event: unknown.Medical device expiration date: na.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 when using the bd sharps coll 7.6l 24 the lid was difficult to close and seal.The following information was provided by the initial reporter.The customer stated: the "cover of the 7.6l sharp box is difficult to seal.".

Manufacturer Narrative

H.6.Investigation: the customer complained of an issue sealing sharps container material# 5460-zkp.No photo or sample was received for testing and the complaint and the failure cannot be verified.The root cause remains unknown.The information received was forwarded to the supplier for further inspection.The production records were reviewed and no abnormalities were presented during production and no further issues have been raised with this product/ lot.

Event Description

It was reported when using the bd sharps coll 7.6l 24 the lid was difficult to close and seal.The following information was provided by the initial reporter.The customer stated: the "cover of the 7.6l sharp box is difficult to seal.".

• Brand Name: BD SHARPS COLL 7.6L 24
• Type of Device: SHARPS CONTAINER
• 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 ; 8015296192
• MDR Report Key: 13031892
• MDR Text Key: 285158028
• Report Number: 2243072-2021-02938
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5460-ZKP
• Device Lot Number: 1E804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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