MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G X 1 IN.; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305916

Device Problem Complete Blockage (1094)

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

Event Date 11/01/2022

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.The initial reporter also notified the fda on 12-dec-2022.Medwatch report # mw5113489.

Event Description

It was reported that the bd safetyglide¿ needle only, 25 g x 1 in.Experienced resistance when attempting to push out air.The following information was provided by the initial reporter: nurses noted resistance in 1-inch safety glide needles when attempting to push out air from syringe.Nurse noted resistance even after removing cap from the needle.Issue was noted in several different needles within the same lot (1333401).Fda safety report id # (b)(4).

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number 305916 and lot number 1333401.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h10.

Event Description

It was reported that the bd safetyglide¿ needle only, 25 g x 1 in.Experienced resistance when attempting to push out air.The following information was provided by the initial reporter: nurses noted resistance in 1-inch safety glide needles when attempting to push out air from syringe.Nurse noted resistance even after removing cap from the needle.Issue was noted in several different needles within the same lot (1333401).Fda safety report id # (b)(4).

• Brand Name: BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G X 1 IN.
• 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: 16032013
• MDR Text Key: 308368658
• Report Number: 1213809-2022-01298
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

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 Catalogue Number: 305916
• Device Lot Number: 1333401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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