MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	300253
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd hypoint¿ had sterility issue.The following information was provided by the initial reporter: "i work at biogen and am working on a complaint that we received regarding a bd needle used with the avonex pen.The complaint issue was regarding the sterility of the needle, which caused a serious adverse event.I have put the exact complaint description below.I am looking to have the needle lot investigated, or the documentation reviewed to ensure that it was manufactured and sterilized according to specifications, with results provided in a report.The bd needle lot is 1105352.Is this something that you can help with?.
Additional Manufacturer Narrative
E.1.The customer's address is unknown.Unknown, (b)(6) has been used as a default.H.6.Investigation summary: unconfirmed: no evidence provided.

• Brand Name: BD HYPOINT¿
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18881664
• Report Number: 8041187-2024-00024
• Device Sequence Number: 21099522
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: (01)00382903002535
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 300253
• Device Lot Number: 1105352
• 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: 02/27/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown