MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; 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	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and mfr site., 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.Device expiration date: unknown.Initial reporter state: the state was determined to be (b)(6) based on the area code portion of the provided phone #.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ sharps collector experienced a missing slide closure door.The following information was provided by the initial reporter: all containers are missing the sliding lid making them unusable.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 1328937.D.4.Medical device expiration date: unknown.D.10.Device available for eval: yes.D.10.Returned to manufacturer on: 04-aug-2022.H.4.Device manufacture date: 01-dec-2021.H.6.Investigation summary: product sample was returned by the customer.5 sample received with 5 lids and one of the lid was broken and all lids had missing inner sliding lids.Investigation performed and issue confirmed.According to the dhr review process; the result showed there were no issues reported like missing slider 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 issue reported for missing slider for the same part number throughout the last twelve months.According to the pictures provided, it can be seen the following: ¿ the inner sliding lids are missing from all the products.¿ one lid is broken.¿ the product is packed in its original packaging.Customer describes that all containers are missing the sliding lid.With that explanation and pictures received, we can confirm the lack of slider as related to the manufacturing process since this issue had already been identified within the process.In regards to the broken lid, there are many variables that could generate this failure mode because the controls to handle the material once is out of flex¿s is unknown, therefore, the likelihood of non-controlled handling within distributor facilities could happen.Furthermore, the current process was reviewed and confirmed that assembly between lid and slider is performed manually and inspected visually per production department and a second inspection based on aql sampling plan is performed by quality department.This process has been confirmed as capable to detect this kind of issues (missing slider and broken lid), however, omission error within the process could happen.Regarding the missing slider issue, a review of customer complaint records was conducted and the results showed that one additional complaint was received during the last twelve months for the same product and issue, for this reason, this problem has been considered an isolated issue and no further investigation is required.There was only one complaint reporting the same issue of broken lid for the same part number during the last twelve months.
Event or Problem Description
It was reported that the bd¿ sharps collector experienced a missing slide closure door.The following information was provided by the initial reporter: all containers are missing the sliding lid making them unusable.

• Brand Name: BD¿ SHARPS COLLECTOR
• 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: 15090036
• Report Number: 2243072-2022-00999
• Device Sequence Number: 5049340
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: 00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 305609
• Device Catalogue Number: 305609
• Device Lot Number: 1328937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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