MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305167
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd precisionglide needle has a hole on the hub and leaked.This is 2 of 2 related events.The following information was provided by the initial reporter: the or supervisor just told me that they are experiencing some quality issues with the precision glide needle21g ½ lot 2245181.There is a hole on the plastic part of the needle so when the staff tries to pull some liquid it sucks in air and when they try to push in liquid is seeps out.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported there is a hole on the plastic part of the needle.To aid in the investigation, two samples in opened packaging blisters and one photo was provided for evaluation by our quality team.A visual inspection was performed with 10x magnification and the samples have a molding short shot about 3/8" from the bottom of the needle hub.The samples were connected to a syringe with saline solution.There is leakage of solution through the molding short shot.The photo provided shows a packaging blister top web for material 205167.No other defects or imperfections were observed.After analysis of the sample and the molding tool, it was determined that stripper bushing wear contributed to the defect reported.A device history record review was completed for provided material number 305167, lot 2245181.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.The stripper bushing was replaced on 17 february 2023.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.We appreciate you taking the time to bring this observation to our attention.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 PRECISIONGLIDE NEEDLE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16882170
• Report Number: 1911916-2023-00277
• Device Sequence Number: 18007463
• Product Code: FMI
• UDI-Device Identifier: 00382903051670
• UDI-Public: (01)00382903051670
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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 Catalogue Number: 305167
• Device Lot Number: 2245181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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