MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿HYPODERMIC NEEDLE; 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	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.H.6.Investigation summary: unconfirmed: no evidence provided.
Event or Problem Description
It was reported that 3 of the bd hypoint¿hypodermic needles had foreign matter.Report 1 of 2.The following information was provided by the initial reporter: the patient reported that all 3 syringes from last delivered of medication were defective.The plungers handles were not attached to gray stopper inside the syringe, plungers would not work on any of the syringes, needles were off set there was something white around the needles that "don't think that should have been there." unknown if the product is on hand for return.Unknown if the md is aware.Unknown if the patient administered the product.Unknown if the patient missed any doses due to the defective items.Unknown if the md is aware.Unknown date of occurrence.Unknown if the patient experienced any side effects due to a defective product.No further information, dates, or details reported.Consent to contact the patient's hcp was not asked.All known information is contained on this form.

• 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: 19161638
• Report Number: 3014704491-2024-00052
• Device Sequence Number: 7382160
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 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): 04/18/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 300253
• Device Lot Number: 0288366
• 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: 04/12/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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