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

Catalog Number 305916

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd safetyglide¿ needle was loose on the syringe and separated from the hub during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "loose needle attached to the syringe.Needle separated from the holder.".

Event Description

It was reported that the bd safetyglide¿ needle was loose on the syringe and separated from the hub during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "loose needle attached to the syringe.Needle separated from the holder.".

Manufacturer Narrative

H6: investigation summary no samples or photos received by our quality team for evaluation.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the quality team¿s investigation, the root cause of the incident clogged needle can be traced to the manufacturing process.During review of the process, process variations during the needle lubricant application can create clogged needles.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.Based on the quality team's investigation, we are not able to identify a root cause for needle pulled out of hub related to our manufacturing process at this time.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859252
• MDR Text Key: 307777249
• Report Number: 1213809-2022-01084
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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
• Device Operator: Other
• Device Catalogue Number: 305916
• Device Lot Number: REGN2117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1