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

Model Number	300253
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle experienced leakage.The following information was provided by the initial reporter: the patient commented that she was affected by abdominal edema with severe pain and continued to apply the medication firazyr icatibant prefilled syringe as usual.He says that he has applied it for years and never had a problem.This time, she says that the syringe was faulty since the medication spilled out of the syringe and when the plunger was pressed, air entered it.She comments that at that moment she became very nervous, she had another dose and it was applied correctly.Of the dose that comments on the failure, it says that none of the product could be applied.The patient reported with some doubts, to ensure the information to be as accurate as possible in the report, i asked her if the medication flowed through the plunger part of the syringe or through the connection between the syringe and the needle and she answered "at that moment i got very nervous, now you make me doubt but i think it was by the plunger part¿.
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for leakage from connector detected during market usage of the product.Only 4 photos and 1 video was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.The description of the issue is unclear it is not possible to investigate the reported condition, determine the root cause or link to a quality criteria in the customer specification.As this is a market event, the reported condition detected is not part of a sampling plan that allows to conclude about the whole batch, therefore the aql is not applicable.The batch was manufactured and released according to applicable procedures and specifications.Consequently, bdm-ps will not define corrective or preventive actions following the investigation of this complaint.This complaint is registered in bd complaint system and trend analysis will be performed.The batch involved in this complaint meets all acceptable quality levels (aql¿s), was manufactured, and released according to applicable procedures and specifications.A review of the quality history within the sap system has been performed as part of the investigation.No quality notifications were identified during the production which relate to the reported condition.Unconfirmed: bd could not confirm the reported condition.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16018755
• Report Number: 8041187-2022-00757
• Device Sequence Number: 17866135
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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 Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: 0106994
• 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: 12/02/2022
• Initial Report FDA Received Date: 12/20/2022
• 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
• 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