MAUDE Adverse Event Report: BECTON DICKINSON BD¿ EXTRA LARGE 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	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.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.
Event or Problem Description
It was reported that the bd¿ extra large sharps collector slide lip was missing.The following information was provided by the initial reporter: the lids do not have the slider to close and lock the bin to prevent the sharps from falling out.Customer disposed of the item and we ordered new ones for the practice.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer "the lids do not have the slider to close and lock the bin to prevent the sharps from falling out could not be verified due to the product not being returned for failure investigation.Based on the information provided, the dhr review process was unable to be performed since there was no lot number provided.A review of the ncmr¿s was performed; the result showed one issues reported for the same part number and issue throughout the last twelve months.Investigation: according to this investigation, there is not enough information provided from customer like a picture showing the nonconformance or a lot number, however within the report, customer describes that lids did not have the slider to close and lock the bin to prevent the sharps from falling out.With that explanation, we can confirm it as related to the manufacturing process since this issue had already been identified within the process.Additionally, 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), however, omission error within the process could happen.Additionally, a review of customer complaint records was conducted and the results showed that four additional complaints were received during the last twelve months for the same product and issue.These previous complaints were closed as manufacturing related and retraining of the personnel was made at the time of receiving them.As part of the containment action, quality alert will be posted in order to aware all the personnel involved in the manufacturing process of this product.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: omission error within the visual inspection.Containment action: quality alert was posted to aware all the personnel involved in the lid manufacturing process.Conclusion: based on this investigation it was determined that this failure mode is related to the manufacturing process since the lack of slider would be an omission error within the process.The current manufacturing process was reviewed, and it was found as capable of detecting missing components, however, omission error could happen during visual inspection.Quality alert was posted within the process in order to make aware all the people involved in the manufacturing process of this product.
Event or Problem Description
It was reported that the bd¿ extra large sharps collector slide lip was missing.The following information was provided by the initial reporter: the lids do not have the slider to close and lock the bin to prevent the sharps from falling out.Customer disposed of the item and we ordered new ones for the practice.

• Brand Name: BD¿ EXTRA LARGE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16550443
• Report Number: 2243072-2023-00396
• Device Sequence Number: 6042925
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/29/2023

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: 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: 02/21/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/05/2023
• 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