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

Model Number	305343
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: 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¿ multi-use nestable sharps collector hinge cap 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.According to the customer's report, one lid was found to be missing upon unpacking.
Event or Problem Description
It was reported while using bd¿ multi-use nestable sharps collector hinge cap 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.According to the customer's report, one lid was found to be missing upon unpacking.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.This is a report about a missing lid of sharps collector.According to the customer's report, one lid was found to be missing upon unpacking could not be verified due to the product not being returned for failure investigation.Device history record review process was no able to be performed to verify if there were issues reported like missing lids since no lot number was provided.A review of non-conformance material report was performed; the result showed that no missing lids issues were reported for the same part number throughout the last twelve months.H3 other text : see h10.

• Brand Name: BD¿ MULTI-USE NESTABLE SHARPS COLLECTOR HINGE CAP
• 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: 16624166
• Report Number: 2243072-2023-00492
• Device Sequence Number: 14785848
• 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): 04/25/2023

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: 305343
• Device Catalogue Number: 305343
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/09/2023
• 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