MAUDE Adverse Event Report: BECTON DICKINSON BD EMERALD¿ - 3-PIECE SYRINGE; PISTON SYRINGE

Catalog Number 307752

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: there are no samples and one photograph along with the reported complaint of rust.The investigating team has used the retention samples of material number: 307752 and lot number: 1361997 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for rust and no rust was found in the ten retention samples.Based on the photograph, the defect could not be confirmed as the visible rust could also be dried blood stains.To confirm the defect and to investigate further the original samples will be required.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.The dhr of material no.307752 with batch no.1361997 was checked and there was no quality notification found on this lot no.From its production date to its dispatch on date.

Event Description

It was reported that 300 bd emerald¿ - 3-piece syringe needles were rusted.The following information was provided by the initial reporter: in box of emerald 3 ml *22g few of needle were rusted.

• Brand Name: BD EMERALD¿ - 3-PIECE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15407429
• MDR Text Key: 306168076
• Report Number: 2243072-2022-01493
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• 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
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 307752
• Device Lot Number: 1361997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• 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