MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL25GA5/8IN; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	300253
Medical Device Problem Codes	Leak/Splash (1354); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.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 syringe 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.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.
Event or Problem Description
It was reported hypoint ndl25ga5/8in leaked during use.The following information was provided by the initial reporter: "a customer who is an experienced user of the product has injected with this needle on (b)(6) 2021 at 12:15 p.M.Some of the solution leaked, defective syringe and needle.

• Brand Name: HYPOINT NDL25GA5/8IN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12321980
• Report Number: 8041187-2021-00729
• Device Sequence Number: 4980446
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 01/31/2024
• Device Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: 9009931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1