MAUDE Adverse Event Report: BECTON DICKINSON BD¿ EXTRA LARGE SHARP COLLECTOR, RED, 9 GAL; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305616
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd¿ extra large sharp collector, red, 9 gal the lid was missing.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a missing lid of sharps collector.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received.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 no issues reported for missing lids for the same part number throughout the last twelve months.According with this investigation there is not enough information provided from customer such as lot number or pictures of the original packaging in order to determine the root cause of this issue.
Event or Problem Description
It was reported while using bd¿ extra large sharp collector, red, 9 gal the lid was missing.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a missing lid of sharps collector.

• Brand Name: BD¿ EXTRA LARGE SHARP COLLECTOR, RED, 9 GAL
• 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: 16269578
• Report Number: 2243072-2023-00096
• Device Sequence Number: 18000953
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: (01)00382903056163
• 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): 02/14/2023

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: 305616
• Device Catalogue Number: 305616
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/04/2023
• 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