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

Model Number 305916

Device Problem Complete Blockage (1094)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 clogged.The following information was provided by the initial reporter: can you please provide additional details in regards to the issue? the needles wont inject any fluid like the needle is clogged up did you experience any adverse events as a result of this reported defect? no adverse events.

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.

Event Description

It was reported that the bd safetyglide¿ needle was clogged.The following information was provided by the initial reporter: can you please provide additional details in regards to the issue? the needles wont inject any fluid like the needle is clogged up did you experience any adverse events as a result of this reported defect? no adverse events.

• 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: 16036322
• MDR Text Key: 308382603
• Report Number: 1213809-2022-01300
• Device Sequence Number: 1
• Product Code: FMI
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305916
• Device Catalogue Number: 305916
• Device Lot Number: 2024137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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