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

Catalog Number	305343
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.Medical device expiration date: na.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 that the bd¿ multi-use nestable sharps collector had no lid.The following information was provided by the initial reporter, translated from japanese: "this is a report about a missing lid of sharps collector.During the inspection after product arrival at the customer's side, one lid was found to be missing.".
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by the customer.This is a report about a missing lid of sharps collector during the inspection after product arrival at the customer's side, one lid was found to be missing could not be verified due to the product not being returned for failure investigation.According to the device history review review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot number (2220954) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed that no missing lids issues were reported for the same part number throughout the last twelve months.Weight records: the weighing database was evaluated to confirm that every box manufactured under the lot number reported was packaged with the correct quantity of lids at the time to perform the packing process.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non-controlled handling within distributor facilities.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
It was reported that the bd¿ multi-use nestable sharps collector had no lid.The following information was provided by the initial reporter, translated from japanese: "this is a report about a missing lid of sharps collector.During the inspection after product arrival at the customer's side, one lid was found to be missing.".

• 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 ; 8448235433
• MDR Report Key: 16427770
• Report Number: 2243072-2023-00253
• Device Sequence Number: 14776764
• Product Code: FMI
• UDI-Device Identifier: 00382903053438
• UDI-Public: 00382903053438
• 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): 03/20/2023

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 Catalogue Number: 305343
• Device Lot Number: 2220954
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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