MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 1 1/2 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305167
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd® needle 1 1/2 in.Single use, sterile needle the hub was damaged and leaked.The following was received from the initial reporter: this occurred again today with one of our providers - injection contents were expressed through a pin hole in the side of the hub of the needle (not where the hub seats down onto the syringe).
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
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 12-sep-2023.H.6.Investigation summary: it was reported the injection contents were expressed through a pin hole in the side of the hub of the needle.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the needle hub has a molding short shot about 3/16" from the bottom of the needle hub.No other defects or imperfections were observed.Previous investigations have confirmed a short shot from the molding process has induced a similar symptom.After analysis of the molding tool, it was determined stripping bushing wear contributed to the symptom reported.A device history record review was completed for provided material number 305167, lot 2228394.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 (b)(6) 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.
Event or Problem Description
It was reported that while using the bd® needle 1 1/2 in.Single use, sterile needle the hub was damaged and leaked.The following was received from the initial reporter: this occurred again today with one of our providers - injection contents were expressed through a pin hole in the side of the hub of the needle (not where the hub seats down onto the syringe).

• Brand Name: BD® NEEDLE 1 1/2 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: 17699888
• Report Number: 1911916-2023-00640
• Device Sequence Number: 12640120
• Product Code: FMI
• UDI-Device Identifier: 30382903051671
• UDI-Public: (01)30382903051671
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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 Catalogue Number: 305167
• Device Lot Number: 2228394
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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