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

Model Number	305343
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that 2 bd¿ multi-use nestable sharps collector are missing labels.The following information was provided by the initial reporter, translated from (b)(6) to english: this is a report about a missing label of sharps collector.During the inspection at the customer's side, it was found that there was no label affixed to the base.
Event or Problem Description
It was reported by the customer that 2 bd¿ multi-use nestable sharps collector are missing labels.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a missing label of sharps collector.During the inspection at the customer's side, it was found that there was no label affixed to the base.
Additional Manufacturer Narrative
H6.Investigation summary: according to the dhr review process, the result showed there were no issues reported as missing label during the manufacturing process of the lot number (1297904) reported under this customer complaint.Also, a review of the ncmr¿s was performed; the result showed there was only one ncmr reported for the same issue and part number throughout the last twelve months.Based on this investigation and information provided such as pictures and description of the issue, we are able to confirm that this product was manufactured by flex on october 24, 2021 and within the report description, mentioning that there was no label affixed to the base, we can identify this issue as a failure mode related to the manufacturing process due to process omission.

• Brand Name: BD¿ MULTI-USE 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15749474
• Report Number: 2243072-2022-01898
• Device Sequence Number: 20393651
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: (01)50382903053433
• 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): 11/16/2022

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: 305343
• Device Catalogue Number: 305343
• Device Lot Number: 1297904
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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