MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	306616
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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 that the bd safetyglide¿ needle was clogged.The following information was provided by the initial reporter: having trouble drawing up medication due to the clogging issue.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr 8994415 ¿ follow up mdr for device evaluation.It was reported there was a clogging issue.As a sample was not returned, a thorough sample evaluation could not be completed.A device history record review was completed for provided material number 306616, lots 2202913 and 2202914.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batches 2202913 and 2202914 were inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Additional device histories were reviewed for each batch of needles used in the manufacturing of these batches.There was no documentation for this type of defect during the entire production run of these batches.Previous investigations have determined that process variations during the needle lubricant application can induce clogged needles.Several quality initiatives have been implemented in the manufacturing process to ensure the needle lubrication is applied appropriately.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.Based on the investigation and with no sample analysis the symptom reported by the customer could not be 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 SAFETYGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17928110
• Report Number: 1213809-2023-01142
• Device Sequence Number: 6435418
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: 10612479248578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 306616
• Device Lot Number: 2202914
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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