MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE

Catalog Number 300865

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: no photos or physicals samples that display the reported issue were provided for investigation.A device history review was performed for lot 1903231, finding one annotation in the daily incident report related to the alleged defect.During the assembly process, a failure was detected in the assembly station that resulted in stoppers that were incorrectly assembled not being properly rejected.Once identified, the mechanical team repaired the failure and impacted units were scrapped.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.A camera system is used in the assembly machine to detect missing or improperly assembled stoppers.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: based on our investigation, it was determined this incident occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly and the detection system failing to reject the improperly assembled units.Updates have been made to this system to prevent any reoccurrence of this issue, the reported lot manufactured prior to the implementations.Manufacturing personnel have been notified of this incident to increase awareness.Rationale: corrective action cor-528-19 was implemented in november 2019, (after this lot was manufactured) vision system of this assembly machine in order to avoid stopper bad assembled defect.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the bd plastipak¿ concentric luer lock syringe plunger had difficult movement and caused leakage.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the nurse gave him an intramuscular injection, the disposable syringe used for injection leaked.After the incident, the nurse immediately removed the needle and re-sterilized the injection site and replaced the syringe,continue to intramuscularly.Immediately after the injection, it called the equipment department.After receiving the notice, the equipment department immediately dispatched relevant personnel to check.After inspection, it was found that the injection plunger of the disposable syringe was not tightly integrated with the jacket, which caused the leakage.The equipment division immediately notified the dealer and the manufacturer, and instructed the dealer and the manufacturer to find out the cause.This incident caused a second puncture to the patient, which increased the possibility of the patient's infection, and the injection dose was not accurate, causing no other harm to the patient.".

Manufacturer Narrative

H6: investigation summary: no photos or physicals samples that display the reported issue were provided for investigation.A device history review was performed for lot 1903231, finding one annotation in the daily incident report related to the alleged defect.During the assembly process, a failure was detected in the assembly station that resulted in stoppers that were incorrectly assembled not being properly rejected.Once identified, the mechanical team repaired the failure and impacted units were scrapped.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.A camera system is used in the assembly machine to detect missing or improperly assembled stoppers.Based on our investigation, it was determined this incident occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly and the detection system failing to reject the improperly assembled units.Updates have been made to this system to prevent any reoccurrence of this issue, the reported lot manufactured prior to the implementations.Manufacturing personnel have been notified of this incident to increase awareness.H3 other text : see h.10.

Event Description

It was reported that the bd plastipak¿ concentric luer lock syringe plunger had difficult movement and caused leakage.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse gave him an intramuscular injection, the disposable syringe used for injection leaked.After the incident, the nurse immediately removed the needle and re-sterilized the injection site and replaced the syringe,continue to intramuscularly.Immediately after the injection, it called the equipment department.After receiving the notice, the equipment department immediately dispatched relevant personnel to check.After inspection, it was found that the injection plunger of the disposable syringe was not tightly integrated with the jacket, which caused the leakage.The equipment division immediately notified the dealer and the manufacturer, and instructed the dealer and the manufacturer to find out the cause.This incident caused a second puncture to the patient, which increased the possibility of the patient's infection, and the injection dose was not accurate, causing no other harm to the patient.".

• Brand Name: BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11103460
• MDR Text Key: 233984395
• Report Number: 3003152976-2020-00595
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 300865
• Device Lot Number: 1903231
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1