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

Catalog Number	300253
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Dizziness (2194); Unspecified Gastrointestinal Problem (4491); Alteration in Body Temperature (4568); Swelling/ Edema (4577)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd hypoint¿ needle was clogged.The following information was provided by the initial reporter: patient reported to the nurse case manager via email, "i had to take firazyr early this morning.The lot number is "tsvj09a15" and the expiry is 09/2024.I was only able to inject half of the dose for some reason and then it felt like the plunger was resisting.I have no other doses, but 3 takhzyro still which i haven't been taking.Symptoms: mild swelling in wrist/ hand 48 hours prior, then gi cramping beginning evening on (b)(6) 2024 that worsened until around 2am (b)(6) 2024 with nausea, pain and dizziness, passing out and hot/ cold flashes before i took firazyr.Fir0725.Follow up infor from reporter: "patient also noted, ¿¿does it matter that i already took off the needle and recapped the syringe? i¿m not sure if it was the syringe or the needle that caused the issue to be fair.I have both parts still.¿.
Additional Manufacturer Narrative
H.6 investigation summary: unconfirmed: no evidence provided.
Event or Problem Description
It was reported that the bd hypoint¿ needle was clogged.The following information was provided by the initial reporter: patient reported to the nurse case manager via email, "i had to take firazyr early this morning.The lot number is "tsvj09a15" and the expiry is 09/2024.I was only able to inject half of the dose for some reason and then it felt like the plunger was resisting.I have no other doses, but 3 takhzyro still which i haven't been taking.Symptoms: mild swelling in wrist/ hand 48 hours prior, then gi cramping beginning evening on (b)(6) 2024 that worsened until around 2am (b)(6) 2024 with nausea, pain and dizziness, passing out and hot/ cold flashes before i took firazyr.Fir0725 follow up infor from reporter: "patient also noted, ¿¿does it matter that i already took off the needle and recapped the syringe? i¿m not sure if it was the syringe or the needle that caused the issue to be fair.I have both parts still.¿.

• 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: 19058902
• Report Number: 8041187-2024-00034
• Device Sequence Number: 20341106
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (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): 04/15/2024

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: Lay User/Patient
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 300253
• Device Lot Number: 0106994
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown