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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6 investigation summary: unconfirmed: the batch involved in this complaint meet all acceptable quality levels (aql¿s), was manufactured, and released according to applicable procedures and specifications.A review of the quality history h3 other text : see h.10.
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle was clogged.The following information was provided by the initial reporter: medication would not push through the needle.Patient stated she initially thought she might have hit scar tissue.She removed the needle and tried pushing medication but it would still not flow through the needle after applying a good amount of pressure and force.Patient used a different dose.
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle was clogged.The following information was provided by the initial reporter: medication would not push through the needle.Patient stated she initially thought she might have hit scar tissue.She removed the needle and tried pushing medication but it would still not flow through the needle after applying a good amount of pressure and force.Patient used a different dose.
Additional Manufacturer Narrative
Investigation summary: the batch involved in this complaint meet all acceptable quality levels (aql¿s), was manufactured, and released according to applicable procedures and specifications.A review of the quality history.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.Unconfirmed: no evidence provided.

• 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: 17509038
• Report Number: 8041187-2023-00425
• Device Sequence Number: 20477979
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: (01)00382903002535
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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: 09/30/2024
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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