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

Model Number	305493
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: 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 the hazard label was missing on the bd¿ chemotherapy sharps collector.The following information was provided by the initial reporter: "we got one of our sharps containers with no labeling on the outside.Typically they have like a hazardous label and what not.This one came naked.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-jan-2023.H6: investigation summary once samples were reviewed at upl it was discovered that finished good should include the product label.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that the hazard label was missing on the bd¿ chemotherapy sharps collector.The following information was provided by the initial reporter: "we got one of our sharps containers with no labeling on the outside.Typically they have like a hazardous label and what not.This one came naked.".

• Brand Name: BD¿ CHEMOTHERAPY 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 ; 8015296192
• MDR Report Key: 16251080
• Report Number: 2243072-2023-00078
• Device Sequence Number: 5473536
• Product Code: FMI
• UDI-Device Identifier: 00382903054930
• UDI-Public: 00382903054930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/13/2023

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: 305493
• Device Catalogue Number: 305493
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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