MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLL 9GAL RED; 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	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.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 sharps coll 9gal red there was a missing part of the lid.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about a lid issue.According to the customer¿s information, there was a lid in which the sliding part was missing.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received.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 are only one 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 could not be determined.
Event or Problem Description
It was reported while using bd sharps coll 9gal red there was a missing part of the lid.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about a lid issue.According to the customer¿s information, there was a lid in which the sliding part was missing.

• Brand Name: BD SHARPS COLL 9GAL 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14547269
• Report Number: 2243072-2022-00741
• Device Sequence Number: 5172532
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: 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): 06/07/2022

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: 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: 05/02/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/07/2022
• 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