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

Model 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	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for needle separates from the syringe detected during market usage of the product.No sample or photo 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.In addition to this, the end-user refers to a ¿clear piece that holds the needle disconnected¿.Hypoint needle does not have a ¿clear piece¿ and bd cannot take into account this information for the investigation.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.
Event or Problem Description
It was reported while using bd hypoint¿ hypodermic needle the needle pulled out of the hub.There was no report of patient impact.The following information was provided by the initial reporter: patient stated the needle fell after he attached it to the syringe.He stated the needle did screw into the syringe but when he took off the needle top it fell.Patient stated that the needle attached to the syringe just fine with no issues, but then all of a sudden the needle just fell off.Clarification provided, the orange needle hub stayed on the syringe however the clear piece that holds the needle disconnected from the orange part, and the needle and clear part fell off.He tried to reconnect but it wouldn't hold.He did not miss a dose as he had another needle to use.He was able to obtain another needle from cvs so he is not missing a needle.
Additional Manufacturer Narrative
Investigation summary: no sample or photo 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.In addition to this, the end-user refers to a ¿clear piece that holds the needle disconnected¿.Hypoint needle does not have a ¿clear piece¿ and bd cannot take into account this information for the investigation.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), were 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.
Event or Problem Description
It was reported while using bd hypoint¿ hypodermic needle the needle pulled out of the hub.There was no report of patient impact.The following information was provided by the initial reporter: patient stated the needle fell after he attached it to the syringe.He stated the needle did screw into the syringe but when he took off the needle top it fell.Patient stated that the needle attached to the syringe just fine with no issues, but then all of a sudden the needle just fell off.Clarification provided, the orange needle hub stayed on the syringe however the clear piece that holds the needle disconnected from the orange part, and the needle and clear part fell off.He tried to reconnect but it wouldn't hold.He did not miss a dose as he had another needle to use.He was able to obtain another needle from cvs so he is not missing a needle.

• 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: 15748204
• Report Number: 8041187-2022-00648
• Device Sequence Number: 15043934
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: Other
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/18/2022
• 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