MAUDE Adverse Event Report: BECTON DICKINSON BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L; 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	05/23/2023
Type of Reportable Event	Malfunction
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.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ next generation patient / exam room sharps collector, 5.1l were missing the lid.The following information was provided by the initial reporter, translated from japanese to english: the customer reported about missing the sliding lid.When checked before use, there was no sliding lid.
Event or Problem Description
It was reported that the bd¿ next generation patient / exam room sharps collector, 5.1l were missing the lid.The following information was provided by the initial reporter, translated from japanese to english: the customer reported about missing the sliding lid.When checked before use, there was no sliding lid.
Additional Manufacturer Narrative
Investigation summary 1 sample received and verified the customer reported complaint about missing the sliding lid.When checked before use, there was no sliding lid.According to the device history record review process, the result showed there were no issues reported as missing component (door) during the manufacturing process for the lot number reported (2277944).A review of the non-conformance material report was performed; the result showed there were no issues reported like missing component (door) for the same part number throughout the last twelve months.According with this investigation and evidence provided it can be seen the following: the internal door of the lid is not assembled.With the lot number 2277944, it can be confirmed this product was manufactured on 10/04/2022.Customer describes that when they checked before use, there was no sliding lid.Under this evidence, we can determine this issue as manufacturing related since this type of problem could be caused by operator omission during the assembly between the door and lid.For this reason, as part of containment actions an awareness and quality alert will be implemented to alert the personnel involved and help on the prevention of lack of components (door).Additionally, the current process was reviewed and confirmed that assembly between lid and door 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 door), however, omission error within the process could happen.As part of this investigation, a review of customer complaint records was performed for this part number; according with the cc¿s records, there is no additional records received in the last twelve months reporting this issue, for this reason, this problem has been considered an isolated issue and no further investigation is required.As per the sample being received, an investigation could be performed, and a root cause could be determined as : 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 door would be an omission error within the process.The current manufacturing process was reviewed and it was found as capable of detecting missing components such as doors, however, omission error could happen during visual inspection.Additionally, this is an isolated issue since there was no additional complaints received for the last twelve months for the same part number and issue.

• Brand Name: BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L
• 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: 17159518
• Report Number: 2243072-2023-01049
• Device Sequence Number: 7154686
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)00382903055173
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: 305517
• Device Catalogue Number: 305517
• Device Lot Number: 2277944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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