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

Model Number	300255
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: 1 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.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.
Event or Problem Description
It was reported that the bd hypoint¿ needle experienced foreign matter contamination.The following information was provided by the initial reporter: a box contains black foreign matter inside one needle shield.The defect was found after opening the product folding box and the customer did not use the concerned box.

• Brand Name: BD HYPOINT¿ 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: 16062983
• Report Number: 8041187-2022-00773
• Device Sequence Number: 2044723
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 12/16/2022

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: 06/30/2026
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 1160088
• 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: 12/09/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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