MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ II SYRINGE; PISTON SYRINGE

Catalog Number 300850

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: there are no samples, but two photographs were received from the customer along with the reported complaint of leakage.The investigating team used retention samples of material #300850 from lot #2201429 for investigating the reported defect.The investigation and simulation were carried out on the retention samples where the investigating team functionally tested the samples for leakage and no leakage was found.Based on the photographs, the defect was confirmed as visible blood was noted flowing backwards after the plunger.However, the root cause could not be determined as the probable root cause can only be determined after investigating the original sample.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.300850 with batch no.2201429 was checked and there was no quality notification found on this lot no.From its production date to its dispatch on date.H3 other text : see h10.

Event Description

It was reported that the bd discardit¿ ii syringe experienced leakage, and blood exposure.The following information was provided by the initial reporter: phlebotomist was collecting blood of a patient while collection blood started leaking from barrel as plunger was not fitted well to barrel of the syringe.

• Brand Name: BD DISCARDIT¿ II 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: 15874903
• MDR Text Key: 307802270
• Report Number: 2243072-2022-02046
• 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: 11/11/2022

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: Health Professional
• Device Catalogue Number: 300850
• Device Lot Number: 2201429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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