MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 302995

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd luer-lok¿ syringe sterile, single use foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they have been noticing that some selected syringes have some oil-like residue on the tip of the syringe.We would like some clarification on a few things, what is the residue on the rubber gasket and inside the syringe? if it is silicone lubricant, is it normal to have varying amounts of lubricant in different syringes/lots? does this material have any impact to cells? 1 opened and 2 unopened 10ml syringes lot 2137358.

Event Description

It was reported while using bd luer-lok¿ syringe sterile, single use foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they have been noticing that some selected syringes have some oil-like residue on the tip of the syringe we would like some clarification on a few things, 1.What is the residue on the rubber gasket and inside the syringe? 2.If it is silicone lubricant, is it normal to have varying amounts of lubricant in different syringes/lots? 3.Does this material have any impact to cells? 1 opened and 2 unopened 10ml syringes lot 2137358.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 18-apr-2023.Investigation summary : three samples were provided to our quality team for investigation.Through visual inspection, it was observed that two samples have an acceptable amount of silicone visible on the stopper.One sample was observed to have silicone stringing between the stopper and the roof of the barrel from an excessive amount of silicone on the stopper.Fourier transform infrared spectroscopy (ftir) analysis confirmed oil-like residue is silicone used in the manufacturing process.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.Potential root cause for the excessive silicone defect is associated with the assembly process.A device history record review was completed for provided lot number 2137358.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16772283
• MDR Text Key: 314081161
• Report Number: 1213809-2023-00382
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302995
• Device Lot Number: 2137358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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