MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305343
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections manufacturer name, city and state and mfr site as flextronics is an oem manufacturing site.Investigation summary: based on the information provided from customer, there is not enough evidence like a picture showing the defect on the product to determine the root cause of this issue, however, within the report customer describes that the close-fitting of the lid was not enough and product was deemed defective.Additionally, with lot number provided it can be confirmed that this product was manufactured by flex on (b)(6) 2021.Considering that failure mode is related to damaged parts, the mold was verified to rule out that the issue could be generated by a damaged on the mold, the assessment confirms that mold was free of damages.Based on that assessment, it can be confirmed that the issue could be generated by several variables like incorrect handling, incorrect storage or non-suitable packaging during partial sells, for this reason, sample is needed in order to determine the root cause of this issue.Also, as part of customers functional requirements, a cap (top) fitment functional test inspection is performed by quality assurance personnel based on aql sampling plan.
Event or Problem Description
It was reported that the bd sharps collector 8 qt multi-use nestable experienced ill-fitting lid.The following information was provided by the initial reporter: according to the customer¿s report, the close-fitting of the lid was not enough and this product was deemed defective.

• Brand Name: BD SHARPS COLLECTOR 8 QT MULTI-USE NESTABLE
• 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: 15331870
• Report Number: 2243072-2022-01439
• Device Sequence Number: 12381801
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: 50382903053433
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2022

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: 305343
• Device Catalogue Number: 305343
• Device Lot Number: 1287947
• 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: 08/08/2022
• Initial Report FDA Received Date: 08/31/2022
• 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