MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTIUSE NESTABLE SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305456
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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.
Event or Problem Description
It was reported that the bd¿ multiuse nestable sharps collector lid was deformed.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.According to the customer's report, the shape of the lid was found to be different from the usual one.
Event or Problem Description
It was reported that the bd¿ multiuse nestable sharps collector lid was deformed.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.According to the customer's report, the shape of the lid was found to be different from the usual one.
Additional Manufacturer Narrative
H6: investigation summary as no samples or pictures were received as evidence so no proper investigation performed.A device history record review process to verify if there were any issues reported as incorrect lids during the manufacturing process of this product was not able to be performed since there was no lot number provided.A review of the non-conformance material report was performed, the result showed that non-conformances were reported for the same part number and issue throughout the last twelve months.

• Brand Name: BD¿ MULTIUSE NESTABLE SHARPS COLLECTOR
• 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: 17159652
• Report Number: 2243072-2023-01051
• Device Sequence Number: 20188986
• Product Code: FMI
• UDI-Device Identifier: 00382903054565
• UDI-Public: (01)00382903054565
• 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): 07/12/2023

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: 305456
• Device Catalogue Number: 305456
• Device Lot Number: SEE H.10
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/31/2023
• 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