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

Catalog Number	300253
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd hypoint¿hypodermic needles were missing glue.The following information was provided by the initial reporter: in a visual inspection of 800 needles we have observed 88 needles with a spot that lacks glue inside the hub additionally we found needle with lack of glue in the bottom of the cannula.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: unconfirmed: reported condition was not observed at bd.
Event or Problem Description
It was reported that the bd hypoint¿hypodermic needles were missing glue.The following information was provided by the initial reporter: in a visual inspection of 800 needles we have observed 88 needles with a spot that lacks glue inside the hub additionally we found needle with lack of glue in the bottom of the cannula.

• Brand Name: BD HYPOINT¿HYPODERMIC NEEDLE
• 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: 19930908
• Report Number: 8041187-2024-00069
• Device Sequence Number: 2760650
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: (01)00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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 Catalogue Number: 300253
• Device Lot Number: 1287377
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• 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
• Patient Sex: Unknown