MAUDE Adverse Event Report: BECTON DICKINSON 64L BD¿ EXTRA LARGE SHARPS COLLECTOR, HINGE TOP; 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	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 64l bd¿ extra large sharps collector, hinge top lid was missing.The following information was provided by the initial reporter: the customer reported that the inner lid was missing.
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.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 64l bd¿ extra large sharps collector, hinge top lid was missing.The following information was provided by the initial reporter: the customer reported that the inner lid was missing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 14-jul-2022.H.6.Investigation summary: 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.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.Additionally, this is an isolated issue since there was only two additional complaints received for the last twelve months for the same part number and issue.

• Brand Name: 64L BD¿ EXTRA LARGE SHARPS COLLECTOR, HINGE TOP
• 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: 15182950
• Report Number: 2243072-2022-01231
• Device Sequence Number: 17594667
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: 00382903056095
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: UNKNOWN
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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