MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP; PISTON SYRINGE

Model Number 309657

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that air leaked past the plunger into the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip and allowed insulin to leak out during use.This occurred on 2 separate occasions, but the dates are unknown.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "customer reports syringe issue.Contact states that the plunger on the syringe was letting air in and letting insulin come out through it (opposite side of the needle where the plunger slides).".

Event Description

It was reported that air leaked past the plunger into the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip and allowed insulin to leak out during use.This occurred on 2 separate occasions, but the dates are unknown.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "customer reports syringe issue.Contact states that the plunger on the syringe was letting air in and letting insulin come out through it (opposite side of the needle where the plunger slides).".

Manufacturer Narrative

H.6.Investigation summary: two samples received for investigation, test were performed including leakage and defects on molding for barrel, plunger rod, and/or stopper.Upon observation, there is damage to the barrel.Possible root cause, is barrel damage during manufacturing.As this occurrence would not exceed the acceptable quality limit (aql) for the batch no corrective or preventative actions are proposed in the scope of this complaint.During the documentary review, records of quality notifications that could cause the defect reported by the client were not observed.The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.No non-conforming part that could be attributable to the defect reported by the client was presented.No deviations (quality notifications) were reported during the manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 9694420
• MDR Text Key: 191602703
• Report Number: 9614033-2020-00015
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 8235730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 01/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR