MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 19GAL RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305609
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd sharps collector 19gal red the lid was not able to close.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a deformed lid of sharps collector.The lid could not be closed because the hole in the lid was open the other way than usual.
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.As flextronics is an oem manufacturing site.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received.Additional attempt to get more information were made, however, the customer confirmed that no additional information was available.The device history record review process to verify if there were issues reported like incorrect assembly during the manufacturing process was not able to be performed since not lot number was provided.A review of the non-conformance material report was performed; the result showed no issues reported as incorrect assembly for the same part number throughout the last twelve months.According with this investigation, there was not enough information provided like pictures of the nonconformance or a lot number, however within the report, the issue description states that the lid could not be closed because the hole in the lid was open the other way than usual.With that explanation, we can identify this failure mode (incorrect assembly) as an issue potentially related to the manufacturing process due to process omission by the operator.Additionally, the current process was reviewed and confirmed that the assembly between lid and slider is performed manually and inspected visually per production department.To carry out the assembly between both components, the shape of the edge of the lid is taken as a reference for the correct assembly orientation, therefore, if the sliding door is placed in the opposite way, the correct assembly will not be achieved since the sliding door will be loose.This can be detected when performing the slide closure back-and-forth to ensure proper function (without sliding into locked position).As well, a second inspection based on aql sampling plan is performed by quality department and this process has been confirmed as capable to detect this kind of issue, however, omission error within the process could happen.As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, only one additional complaint was received through the last twelve months for the same part number and issue, being this considered an isolated event.Due to no sample being received, an investigation could be performed on basis of photo representation, and a root cause could be determined as potential root cause as below: omission error within visual inspection.Containment action: quality alert was posted to aware all the personnel involved in the manufacturing process of this product.Conclusion: based on this investigation, it was determined that this failure mode is potentially related to the manufacturing process since the incorrect assembly between lid and slider would be an omission error within the process, however, issue description it¿s not clear and more evidence is needed in order to determine the root cause of the issue reported.The current manufacturing process was reviewed and it was found as capable of detecting wrong assembly of 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 during use with bd sharps collector 19gal red the lid was not able to close.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a deformed lid of sharps collector.The lid could not be closed because the hole in the lid was open the other way than usual.

• Brand Name: BD SHARPS COLLECTOR 19GAL RED
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17389689
• Report Number: 2243072-2023-01305
• Device Sequence Number: 11731322
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• 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,Followup
• Report Date (Section B): 09/06/2023

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 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: 06/30/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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