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

Catalog Number	300253
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bd hypoint¿ ndl25ga5/8in detached from the orange hub.The following information was provided by the initial reporter: patient also reports having 2 defective syringes 1)pt reports experiencing 3 abdominal and laryngeal attacks since their last fill as follows: (b)(6) 2024 severe swelling, (b)(6) 2025 moderate swelling, (b)(6) 2025 moderate swelling.Pt reports that all attacks were treated with 1 dose of prn firazyr each; resolution dates unknown.Pt reports that they had an er visit in (b)(6) 2024 due to an (unspecified) reaction to antibiotics.Dates of admittance and discharge or length of er stay is unknown.Pt also reports having 2 defective syringes.Pt reports that they had a laryngeal attack this morning (b)(6) 2025 and two of their firazyr syringes malfunctioned.Pt reports that with the first syringe the needle fell out of the orange needle hub that attaches to the barrel.Pt had no extra needles so that dose had to be wasted.Consent to contact the patient's hcp was not asked.All known information is contained on this form.2) pt reports the second syringe's plunger malfunctioned and they were only able to get 3/4 of the dose, which was enough med to resolve the attack.Two lot numbers were reported.Pt is unsure which lot number corresponds with the needle that fell off or the defective plunger.During a follow-up with the patient, they reported no missed dosage.The needle detached from the orange hub for the first medication, and there was a plunger malfunction with the second medication, though sufficient medication was administered to halt the attack.However, the patient mentioned discarding both syringes and was uncertain which lot number corresponded to each incident.No harm was reported.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 0288366.D.4.Medical device expiration date: 31-oct-2025.H.4.Device manufacture date: 23-dec-2020.Lot# 03899442 and 03628144 was reported, however, this is not a lot # manufactured for the reported catalog # 300253.E.1.The customer's address is unknown.(b)(6), usa has been used as a default.H3.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 the bd hypoint¿ ndl25ga5/8in detached from the orange hub.The following information was provided by the initial reporter: patient also reports having 2 defective syringes.1) pt reports experiencing 3 abdominal and laryngeal attacks since their last fill as follows: on (b)(6) 2024 severe swelling, on (b)(6) 2025 moderate swelling, on (b)(6) 2025 moderate swelling.Pt reports that all attacks were treated with 1 dose of prn firazyr each: resolution dates unknown.Pt reports that they had an er visit on (b)(6) 2024 due to an (unspecified) reaction to antibiotics.Dates of admittance and discharge or length of er stay is unknown.Pt also reports having 2 defective syringes.Pt reports that they had a laryngeal attack this morning on (b)(6) 2025 and two of their firazyr syringes malfunctioned.Pt reports that with the first syringe the needle fell out of the orange needle hub that attaches to the barrel.Pt had no extra needles so that dose had to be wasted.Consent to contact the patient's hcp was not asked.All known information is contained on this form.2) pt reports the second syringe's plunger malfunctioned and they were only able to get 3/4 of the dose, which was enough med to resolve the attack.Two lot numbers were reported.Pt is unsure which lot number corresponds with the needle that fell off or the defective plunger.During a follow-up with the patient, they reported no missed dosage.The needle detached from the orange hub for the first medication, and there was a plunger malfunction with the second medication, though sufficient medication was administered to halt the attack.However, the patient mentioned discarding both syringes and was uncertain which lot number corresponded to each incident.No harm was reported.
Additional Manufacturer Narrative
H.6.Investigation summary: unconfirmed: bd could not confirm the reported condition.

• 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: 21609397
• Report Number: 8041187-2025-00008
• Device Sequence Number: 9467227
• 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: K070440
• 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,Followup
• Report Date (Section B): 03/19/2025

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: SEE H.10
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 68 YR
• Patient Sex: Unknown