MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT SYRINGE; SYRINGE, PISTON

Catalog Number 301001

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.E.Full account address looked up: (b)(6).Address provided: (b)(6).

Event Description

It was reported that bd discardit syringe leaked past the plunger the following information was provided by the initial reporter: leakage in between the plunger rod and barrel.While retriving the saline for starting the dialysis process followed with blood leakage happened (b)(6) 2023.The healthcare worker did not wear self protective equipment like gloves.They have not demanded or mentioned any treatment needed post exposure of blood/body fluids.

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number 301001 and lot number 2305520.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, two (2) picture samples were received for evaluation by our quality team.Through examination of the pictures, leakage was observed through the plunger rod component.It has been determined that this issue resulted from damage in the plunger lip.This type of damage may be produced during the handling of the product through the manufacturing process or within the plunger assembly machine.Bd recommends the use of three-piece syringes with luer lock tip to administer medication via a syringe pump.The bd three-piece syringe has a natural rubber stopper which provides a smoother performance in terms of plunger advancement at a low speed.In addition, a luer lock fitting ensures a safer connection with the infusion line compared to a luer slip tip, thus reducing the risk of disconnection of the infusion line.It is preferable that the syringe pump is placed at the same height of the patient and horizontal.This is to avoid that the difference in pressure between atmosphere and vein, as it could lead the syringe to empty by its own.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD DISCARDIT SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18159001
• MDR Text Key: 328389983
• Report Number: 3002682307-2023-00328
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903010011
• UDI-Public: (01)00382903010011
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301001
• Device Lot Number: 2305520
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1