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

Model Number	300253
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: investigation summary: the customer issued a complaint for syringes tip was broken.No sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.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.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 h3 : see h.10.
Event or Problem Description
It was reported while using bd hypoint¿ hypodermic needle the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: according to the complaint description, the patient stated that, the icatibant syringes tip was broken and therefore he was not able to inject any medication or use the syringe at all.Unknown if missed dose or adverse events.According to the additional information received by intake center, it is unknown when the needle was broken and it is unknown if the product was dropped or handled roughly.
Event or Problem Description
It was reported while using bd hypoint¿ hypodermic needle the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: according to the complaint description, the patient stated that, the icatibant syringes tip was broken and therefore he was not able to inject any medication or use the syringe at all.Unknown if missed dose or adverse events.According to the additional information received by intake center, it is unknown when the needle was broken and it is unknown if the product was dropped or handled roughly.
Additional Manufacturer Narrative
Investigation summary no sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.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.

• 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 ; 8448235433
• MDR Report Key: 17076104
• Report Number: 8041187-2023-00256
• Device Sequence Number: 6673285
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: (01)00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 06/14/2023

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: 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/26/2023
• 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