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

Catalog Number 305916

Device Problem Complete Blockage (1094)

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

Event Date 11/11/2022

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 blocked during use.The following information was provided by the initial reporter: "lots of resistance when pushing medication through needle some syringes -unable to push medication through needle.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-jan-2023.H6: investigation summary: it was reported that the needles were clogged.To aid in the investigation, two samples in sealed packaging blisters were provided to our quality team for investigation.A visual inspection was performed and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.Both samples expelled the solution with a normal flow.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.A device history record review was completed for provided lot number 2024137.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported could not be confirmed.

Event Description

It was reported that the bd safetyglide¿ needle was blocked during use.The following information was provided by the initial reporter: "lots of resistance when pushing medication through needle some syringes -unable to push medication through needle".

• 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: 16057085
• MDR Text Key: 308480433
• Report Number: 1213809-2022-01315
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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
• Device Operator: Other
• Device Catalogue Number: 305916
• Device Lot Number: 2024137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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