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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2188472.D.4.Medical device expiration date: 30-jun-2027.H.4.Device manufacture date: 07-jul-2022.D.4.Medical device lot #: 2202913.D.4.Medical device expiration date: 30-jun-2027.H.4.Device manufacture date: 21-jul-2022.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 blocked.Lot#: 2188472 and 2202913.The following information was provided by the initial reporter: the needles seem to be blocked as it does not allow to push out the liquid for the injection.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation it was reported the needles seemed to be blocked.To aid in the investigation, three hundred forty-nine samples in sealed packaging blisters were received for evaluation by our quality team.Two hundred ninety-nine samples were from lot 2188472 and forty samples were from lot 2202913.Fifty samples were randomly selected from lot 2188472 and twenty samples were randomly selected from lot 2202913.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.From lot 2188472, three samples did not expel the solution.All the remaining selected samples from both lot expelled the solution with a normal flow.Previous investigations have revealed that process variations during the needle lubricant application can create clogged needles.A device history record review was completed for provided material number (b)(4), lots 2188472 and 2202913.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lots 2188472 and 2202913 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 this batch.During the history review, there were lots identified as having suffered from clogged needles due to silicone.It could be possible some samples are escapes from the incident that occurred during production.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 the returned sample analysis the symptom reported by the customer 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.H3 other text : see h10 manufacture narrative.

• 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: 17927412
• Report Number: 1213809-2023-01133
• Device Sequence Number: 12354437
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: 10612479248578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 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: SEE H.10
• 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: 09/28/2023
• 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): 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