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

Model Number	300253
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for clogged needle detected during end customer use.No samples or photo were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint met all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.As no sample was provided to bdm-ps for analysis and no additional information is available, the 8d team leader is not able to delve deeper into the investigation and correlate this symptom with a potential cause linked to bdm-ps hypoint manufacturing process.However, based on the description bd assigned a quality criteria that is identified in the agreed specification.After reviewing the occurrence is within the specification and no further action will be assigned and report will not be updated on receipt of additional sample information.Unconfirmed: no evidence provided.
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle was blocked during the icatibant injection.The following information was provided by the initial reporter: "patient with hae carries icatibant injections for emergency treatment.Patient required this treatment and injected himself with the medication as a subcutaneous injection.However the patient was unable to administer the medication due to a needle defect.The patient attended our unit for treatment that was required.It was noted there was no issue with the pre-filled syringe only the needle.Th needle did allow for the medication to be given.On the unit we were able to change the needle and give the medication as prescribed.As this is an emergency treatment it is vital patients have access to this treatment urgently if they need it.".

• 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: 14197766
• Report Number: 8041187-2022-00218
• Device Sequence Number: 1700933
• 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): 04/12/2022

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: 09/30/2024
• Device Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: 9260744
• 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: 04/05/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• 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