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 11/29/2022

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 3 bd safetyglide¿ needles were clogged.The following information was provided by the initial reporter: we have detected faulty bd safety glide injection needles.Needle does not allow to push fluid through it.Having to inject a client more than once to change out the needle, causing increased time, pain and higher likelihood of needle stick injury.

Event Description

It was reported that 3 bd safetyglide¿ needles were clogged.The following information was provided by the initial reporter: we have detected faulty bd safety glide injection needles.Needle does not allow to push fluid through it.Having to inject a client more than once to change out the needle, causing increased time, pain and higher likelihood of needle stick injury.

Manufacturer Narrative

H6: investigation summary: it was reported the needle would not push fluid through it.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution.The sample did not expel the solution; this needle is clogged.A device history record review was completed for provided material number 305916, lot number 2010821.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2010821 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.

• 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: 16071008
• MDR Text Key: 307491026
• Report Number: 1213809-2022-01325
• 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: 01/11/2023

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 Model Number: 305916
• Device Catalogue Number: 305916
• Device Lot Number: 2010821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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