MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 5/8 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305122
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd® needle 5/8 in.Single use, sterile there were holes in device.Verbatim: injuries or adverse event: no.Reported issue: holes in them.Where was the holes located on the device? on the base that¿s holding the needle.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2228030, d4.Medical device expiration date: 11nov2027, h4.Device manufacture date: 16aug2022.D4.Medical device lot #: 3055929, d4.Medical device expiration date: 30apr2028, h4.Device manufacture date: 24feb2023.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd® needle 5/8 in.Single use, sterile there were holes in device.Verbatim: injuries or adverse event: no.Reported issue: holes in them.Where was the holes located on the device? on the base that¿s holding the needle.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 04-aug-2023.H.6.Investigation summary: it was reported there were holes in device.To aid in the investigation, fourteen samples in sealed packaging blisters and one video was provided for evaluation by our quality team.A visual inspection was performed with 10x magnification, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.No leakage or any other issue was observed.The video provided shows a syringe connected to a needle assembly with no plastic shield inserted into a vial.While pressing the plunger rod there is solution leaking from one side of the needle hub.No other defects or imperfections were observed.A device history record review was completed for provided material number 305122, lot 3055929.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.However, based on the video sample analysis the symptom reported by the customer is confirmed, but without a defective sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD® NEEDLE 5/8 IN. SINGLE USE, STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17358228
• Report Number: 1911916-2023-00500
• Device Sequence Number: 6903322
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 08/08/2023

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: Health Professional
• Device Model Number: 305122
• Device Catalogue Number: 305122
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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