MAUDE Adverse Event Report: BECTON DICKINSON AND CO. SYRINGE 0.5ML 31GA 8MM; PISTON SYRINGE

Catalog Number 328468

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter zip code : unknown.Investigation summary : exec summary - no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Capa/sa - based on the investigation, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.Dhr review - a review of the device history record was completed for batch# 0321244.All inspections and challenges were performed per the applicable operations qc specifications.

Event Description

It was reported that 1 bd syringe 0.5ml 31ga 8mm plunger end was unformed.The following information was provided by the initial reporter : material no: 328468 batch no: 0321244.Consumer reported the end of the plunger is not completely formed.Date of event unknown.Sample status unknown.

• Brand Name: SYRINGE 0.5ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11893465
• MDR Text Key: 255466603
• Report Number: 9616656-2021-00593
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: 0321244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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