MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 5.4QT RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).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.Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 bd sharps collectors 5.4qt red had the lid missing.The following information was provided by the initial reporter: "it was reported i have 3 of the sharps container red 5.4qt your item number 305517 without the lids.".
Event or Problem Description
It was reported that 3 bd sharps collectors 5.4qt red had the lid missing.The following information was provided by the initial reporter: " it was reported i have 3 of the sharps container red 5.4qt your item number 305517 without the lids.".
Additional Manufacturer Narrative
Investigation summary: photos of the affected sharps container were received and investigated by our quality team.The information was also forwarded to the supplier to find possible root cause.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lid issue for the same part number throughout the last twelve months.The root cause remains unknown but one possible issue is mishandling by distributor during repackaging.

• Brand Name: BD SHARPS COLLECTOR 5.4QT RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 13446728
• Report Number: 2243072-2022-00144
• Device Sequence Number: 4304682
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: 00382903055173
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 305517
• Device Catalogue Number: 305517
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown