MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORTS; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305635
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of bd¿ phlebotomy sharps containers with needle ports were received without lids.The following information was provided by the initial reporter: "we received an email from cx that they received the item but these sharp containers did not come with any lids.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by customer that "received the item but these sharp containers did not come with any lids" could not be verified due to the product not being returned for failure investigation.Based on the information provided, the device history record review process was unable to be performed since there was no lot number provided.A review of the ncmr¿s was performed; the result showed no issues reported for missing lids for the same part number throughout the last twelve months.According with this investigation there is not enough information provided from customer such as lot number or pictures of the original packaging in order to determine the root cause of this issue.The variables that could generate this failure mode such as handling, transportation, storage or partial sales from distributor are unknown.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since information such as method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility is unknown.
Event or Problem Description
It was reported that an unspecified number of bd¿ phlebotomy sharps containers with needle ports were received without lids.The following information was provided by the initial reporter: "we received an email from cx that they received the item but these sharp containers did not come with any lids.".

• Brand Name: BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORTS
• 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: 15890022
• Report Number: 2243072-2022-02069
• Device Sequence Number: 12460733
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: (01)00382903056354
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

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: 305635
• Device Catalogue Number: 305635
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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