MAUDE Adverse Event Report: BECTON DICKINSON BD¿ EXTRA LARGE SHARPS COLLECTOR, HINGE TOP WITH GASKET; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305609
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ extra large sharps collector, hinge top with gasket the lid was missing.There was no report of patient impact.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.Injuries or adverse event: no item: 305609 quantity affected: 1 case serial/lot number: (b)(4).Reported issue: they took that out of the box and when they went use them they noticed the tops are missing the sliding portion of the top.Bd¿s manufacturing must have not included them.
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event is unknown; awareness date has been used for this field.Medical device expiration date: na.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 while using bd¿ extra large sharps collector, hinge top with gasket the lid was missing.There was no report of patient impact.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.Injuries or adverse event: no.Item: 305609.Quantity affected: 1 case.Serial/lot number: (b)(6) reported issue: they took that out of the box and when they went use them they noticed the tops are missing the sliding portion of the top.Bd¿s manufacturing must have not included them.
Additional Manufacturer Narrative
Investigation summary: no sample received but photos representation was provided for the complaint.It was reported by the customer "they took out the product from the box and when they wanted to use them they noticed the tops are missing the sliding portion of the top.The pictures were received as evidence showing the lack of slider of the product and confirmed.According to the device history record review process, the result showed there were no issues reported like missing component (slider) during the manufacturing process for the lot number (2261927) reported under this complaint.A review of the non-conformance material was performed; the result showed one issue reported for the same part number and issue throughout the last twelve months.

• Brand Name: BD¿ EXTRA LARGE SHARPS COLLECTOR, HINGE TOP WITH GASKET
• 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 ; 8448235433
• MDR Report Key: 16624708
• Report Number: 2243072-2023-00494
• Device Sequence Number: 20401285
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 04/26/2023

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: 305609
• Device Catalogue Number: 305609
• Device Lot Number: 2261927
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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