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

Catalog Number 5460-ZKP

Device Problem Crack (1135)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that the bd sharps coll 7.6l 24 had a cracked lid.There was no patient involvement.The following information was provided by the initial reporter: "crack lid.".

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.The date received by manufacturer has been used for this field.Medical device expiration date: na.Initial reporter address 1: (b)(6).Initial reporter facility: (b)(6).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 the bd sharps coll 7.6l 24 had a cracked lid.There was no patient involvement.The following information was provided by the initial reporter: "crack lid.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 28-dec-2021.H6: investigation summary: samples were received and tested by our quality team.The cracks were clearly present and the complaint was verified.The investigation was then forwarded to the supplier for discovery of a possible root cause.The supplier found no irregularities or issues with the production and quality inspections of these containers.The root cause remains unknown but it is very possible that the crack occurred during distributing/ repackaging.A device history review was conducted for lot number 1f802 h3 other text : see h10.

• 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: 13259722
• MDR Text Key: 286753182
• Report Number: 2243072-2021-03127
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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: 5460-ZKP
• Device Lot Number: 1F802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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