MAUDE Adverse Event Report: BECTON DICKINSON BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305517
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: 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¿ next generation patient / exam room sharps collector, 5.1l the lid was missing.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: received two containers without lids and couldn't use them.
Event or Problem Description
It was reported while using bd¿ next generation patient / exam room sharps collector, 5.1l the lid was missing.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: received two containers without lids and couldn't use them.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that they receive two containers without lids could not be verified due to the product not being returned for failure investigation.Device history record review process was not able to be performed since there was no lot number provided to verify if there were issues reported like missing lids during the manufacturing process.A review of the ncmr¿s was performed; the result showed no issues for the same part number and issue throughout the last twelve months.According with this investigation there is not enough information provided from customer like pictures of original packaging or lot number.Based on information provided it wasn¿t possible determine the root cause like a failure mode related to the manufacturing process because there is not enough information like a picture from original packaging to perform an exhaustive investigation.H3 other text : see h10.

• Brand Name: BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L
• 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: 16318483
• Report Number: 2243072-2023-00143
• Device Sequence Number: 15478412
• Product Code: FMI
• UDI-Device Identifier: 00382903055173
• UDI-Public: (01)00382903055173
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 305517
• Device Catalogue Number: 305517
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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