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

Model Number	305613
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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 in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: no photos or samples were available.It was reported by customer that " they have problems with the lids" was not verified as no sample available.Device history record review process to verify if there were issues reported as missing lids or lid will not shut issue during the manufacturing process of this product was not able to be performed since no lot number was provided.A review of non-conformance material report was performed; the results exhibit no issues reported for the same part number and issues throughout the last twelve months.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of bd¿ sharps collectors lids had problems closing.The following information was provided by the initial reporter: verbatim: our crews are having problems putting on the sliding lids.
Event or Problem Description
It was reported that an unspecified number of bd¿ sharps collectors lids had problems closing.The following information was provided by the initial reporter: verbatim our crews are having problems putting on the sliding lids.
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the mdr 2243072-2023-01035 is a duplicate of 2243072-2023-00783 this supplemental is to cancel mdr 2243072-2023-01035.

• Brand Name: BD¿ 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: 17144446
• Report Number: 2243072-2023-01035
• Device Sequence Number: 5771906
• Product Code: FMI
• UDI-Device Identifier: 00382903056132
• UDI-Public: 00382903056132
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 06/27/2023

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: 305613
• Device Catalogue Number: 305613
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/13/2023
• 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