MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS CONTAINER

Catalog Number 300183

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as flextronics is an oem manufacturing site.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 that while using bd sharps container, the label was missing.This event occurred 3 times.There was no report of user impact.The following information was provided by the initial reporter: "through this channel i allow myself to report this incident found in one of bd's products, this being the code 300183 3l red sharps collector where they indicate that they do not have the product labeling.For this reason, i request your support and attention in the physical change to make the replacement to the end customer.".

Event Description

It was reported that while using bd sharps container, the label was missing.This event occurred 3 times.There was no report of user impact.The following information was provided by the initial reporter: "through this channel i allow myself to report this incident found in one of bd's products, this being the code 300183 3l red sharps collector where they indicate that they do not have the product labeling.For this reason, i request your support and attention in the physical change to make the replacement to the end customer.".

Manufacturer Narrative

H.6.Investigation: photos of the affected samples were received and tested by our quality team.The photos verified the customer's complaint of missing labels and the investigation was forwarded to the supplier to determine possible root causes.According to the dhr review process, the result showed there were no issues reported like missing label during the manufacturing process of the part number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing label issue for the same part number throughout the last twelve months.The root causes have been narrowed down to product label missing on base due to variation on spaces among labels.-there is not defined a specification for this component.Workstation not suitable for to perform reprocessing the bases (labels) -the workstation must be modified for a better reprocessing of the material h3 other text : see h.10.

• Brand Name: BD SHARPS CONTAINER
• 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: 13056502
• MDR Text Key: 286256386
• Report Number: 2243072-2021-02960
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300183
• Device Lot Number: 1196939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1